Page 11234..1020..»

Category : Low T

Could This Device Help Save Covid-19 Patients Before the ICU? – Houstonia Magazine

ONE OF THE MOST DIFFICULT ASPECTS OF LIFE IN A COVID-19 world is the uncertainty. Not only are we facing an unseen opponent that we barely understand, but none of us know, should we contract the virus, whether well be part of the group that barely registers any symptoms or if well rapidly end up in a drug-induced haze on a ventilator in the ICU. More troubling still, neither do the doctors treating us.

What if there were a way to find out? OncologistDr. Cassian Yee of MD Anderson thinks the key to unlocking this mystery may very well be pumping inside our veins.

For more than 25 years Yee has been studying the use of T-cells, a type of white blood cell called lymphocytes, in his cancer research. They are like soldiers that are trained by the bodys immune system, he says. They go to sites of disease, the battlefield, and coordinate an attack on the enemy, the virus or cancer cell. When their job is completed, they return to the barracks and keep vigilant for any further attacks.

After reading reports that noted lower levels of T-cells in patientswith severe cases ofCovid-19, specificallythose who experiencedrespiratory failure, theoncologist realized thatdeveloping a test to quicklydetermine a patients T-cellcount could go a long waytoward helping medical personnel predict which patients are more prone to experiencing the viruss most deadly symptoms, long before doctors have to get machines to start breathing for them.

Technically this kind of lab test already exists, says Yee; its just not fast or easily available (were talking expensive and bulky equipment and results that take about half a day to process), especially when time is of the essence and equipment is in short supply. So Yee teamed up withKevin McHugh andPeter Lillehoj of Rice University to create a point-of-care device that would allow medical personnel to conduct these tests quickly and cheaply, key factors that could make this item crucial for both Texas Medical Center hospitals and underserved clinics on the front lines of the outbreak.

Using a small amount of blood, the teams point-of-care device will separate the different kinds of blood cells in the sample, count the lymphocytes, and spit out a quantifiable numberideally in about 15 minutes or less. Doctors will then use this number to determine whether a Covid-19 patient is more likely to suffer poor oxygenation. If doctors know beforehand that certain patients have low T-cell numbers and are thus more prone to experiencing the symptoms, including lung deterioration, that have been shown to be fatal in some, they could start more aggressively treating those patients long before they have to be put on ventilators. Its a bit like, Can this patient go home and safely recuperate, or should they stay in the hospital because they might need the ICU? explains McHugh, who specializes in bioengineering.

There are other potential uses for this device as well. While Yee and his team dont expect their point-of-care prototype device to be ready until January 2021 at the earliest, that hasnt stopped them from considering the technologys uses beyond the current coronavirus pandemic.

Wed love to be able to eventually move this into other viral diseases, such as HIV, Yee says. Perhaps even when patients are undergoing some type of treatment for their cancer.

Continue reading here:
Could This Device Help Save Covid-19 Patients Before the ICU? - Houstonia Magazine

Recommendation and review posted by Alexandra Lee Anderson

Equipping the Immune System to Fight Against COVID-19 – BioSpace

The coronavirus that causes COVID-19 has one major advantage over us it is a new human virus. Most people have not encountered the virus before, meaning their immune system is not primed and ready to fight it. When someone gets sick with COVID-19, there is a lag in an efficient immune response, giving the virus time to do significant damage before the immune system can reign in the infection.

It essentially becomes a race between how fast your immune system can clear the virus and how quickly the virus can replicate and induce damage, Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences at AlloVir, told BioSpace.

To develop an effective treatment or vaccine for COVID-19, scientists must understand how the immune system is impacted during the disease. One type of immune cell that is particularly important in the bodys response to COVID-19 is T-cells. T-cells perform many functions, including recognizing invading viruses such as the coronavirus that causes COVID-19.

Multiple studies from Wuhan, China reported that COVID-19 patients had very low T-cell counts; the sicker the patient, the lower their T-cell count. Lower T-cell counts were correlated with poorer outcomes (including higher risk of death) and T-cells isolated from COVID-19 patients also showed signs of exhaustion.

The elderly, patients with low T-cell numbers, and patients who express exhaustion markers on their T-cells are high risk groups in which nave cell responses (responses against a virus they have never seen before) may be deficient or delayed, thus allowing the virus to induce a large amount of damage, Dr. Melian explained. These patients may, therefore, benefit from AlloVirs approach which is designed to restore natural T-cell immunity in high risk patients.

Could giving high-risk COVID-19 patients functional T-cells against the coronavirus boost their immune system and help them recover? This is the question AlloVir aims to answer.

AlloVir creates allogeneic (off-the-shelf) virus-specific T-cells designed to treat common and devastating viral-associated diseases in vulnerable patients, such as those who are immunocompromised or patients who received an organ or stem cell transplant. Now, they are expanding their anti-viral T-cell arsenal and taking aim at COVID-19.

We believe AlloVirs technology is well positioned to treat patients with COVID-19 because our technology is designed to provide SARS-CoV-2 specific T-cell immunity while leaving non-infected cells intact, Dr. Melian commented. Our virus-specific T-cell candidates have been used to treat more than 275 immunocompromised patients with life-threatening viral infections and diseases and we believe it our approach may also have promise in treating COVID-19.

Fighting viruses with T-cells in immunocompromised patients

When you get infected with a virus, your immune system responds to the foreign threat by making specific T-cells that can recognize the virus. These specific T-cells prompt your immune system to destroy any cells infected by the virus.

However, if you have a T-cell deficiency, your immune system cannot robustly protect you. This is a major problem because an otherwise innocuous virus can become a serious infection, causing complications, and possibly even be life-threatening.

That is where AlloVir comes in. They address the underlying problem the weakened immune system. A weakened immune system can be beefed up by giving patients with T-cell deficiencies off-the-shelf virus-specific T-cells (VSTs) originally taken from healthy people. This restores their natural T-cell immunity and helps their immune system fight off the viruses.

At AlloVir, we are a leading innovator in discovering and developing allogeneic, virus-specific T-cell immunotherapies, Dr. Melian said. We are now excited to be applying our capabilities in discovering and developing SARS-CoV-2 specific T-cells to join the fight in developing a COVID-19 program for patients at high risk of severe and devastating disease.

AlloVirs virus-specific T-cell platform

To create AlloVirs T-cell therapies, the target virus is first studied carefully to identify its specific antigens (unique molecules on the outside of each virus that are specific to the virus and alert the immune system). The best antigens those that induce a strong T-cell response are used to create the therapy.

Next, blood is taken from healthy donors who have been exposed to the virus of interest and T-cells are isolated from the blood. The T-cells are activated in the lab they are trained to recognize the identified viral antigens, enabling the T-cells to selectively recognize only the desired virus.

After the T-cells have learned to recognize the specific virus, they are expanded to generate multitudes of cells. Once the activated, specific T-cells are created, they can be cryopreserved and kept for a long time, making them readily available as soon as a patient needs them. The entire process, from antigen selection to donor to ready-to-go T-cell treatment, can be completed in a matter of weeks. This process can be seen in the visual below.

Source: AlloVir

Patients are matched using the companys proprietary human leukocyte antigen (HLA)-matching formula. HLAs are proteins on the surface of cells that regulate the immune system.

Our proprietary donor selection algorithm, known as Cytokin enables us to cover >95 percent of patients in our target population from cells derived from a small number of donors, Dr. Melian said. This proprietary process of prospectively manufacturing cells for off-the-shelf use enables us to study our allogeneic cell therapies in large numbers of patients that suffer from global health crises, like seasonal influenza and, as we are discussing, the COVID-19 pandemic.

These T-cells are advantageous because they are active against a single virus or multiple viruses, are not patient-specific (so they are readily available) and are a single treatment that provides lasting protection. The biggest bonus is the immediate off-the-shelf use for time-sensitive infections in vulnerable populations, added Dr. Melian.

In addition to developing their COVID-19 therapy (called ALVR109), AlloVir has two other multi-virus specific T-cell therapies in development: Viralym-M (ALVR105) and ALVR106. Both therapies focus on treating viral diseases common to stem cell and solid organ transplant patients and other vulnerable populations.

Viralym-M targets six common viruses: BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein-Barr virus (EBV, also called human herpesvirus 4), human herpesvirus 6, and JC virus (also called human polyomavirus 2). Although these viruses are widespread and infect most people, they only cause severe problems in people with weakened immune systems due to age, organ or stem cell transplant, or disease (such as diabetes or AIDS). In a Phase 2 study, 93 percent of 38 allogeneic stem cell transplant patients had a clinical response to Viralym-M treatment and functional Viralym-M cells lasted up to 12 weeks in the patients.

ALVR106 targets four common respiratory viruses: influenza, parainfluenza virus, respiratory syncytial virus (RSV), and human meta-pneumovirus (HMPV). While these viruses tend to cause mild to moderate respiratory illnesses, they can cause severe, life-threatening illness, especially in people with weakened immune systems. ALVR106 is still in preclinical development but clinical trials are expected to begin this year. Overall, AlloVir expects to have three new proof-of-concept (POC) Phase 1b/2 and three pivotal Phase 3 studies started over the next 6-18 months.

Off-the-shelf T-cells against COVID-19

While AlloVir originally designed their T-cell therapies for transplant patients, their platform can potentially be applied to any virus to create virus-specific T-cells. This versatility allowed AlloVir to pivot and create T-cells against SARS-CoV-2, the virus that causes COVID-19. This new investigational therapy, called ALVR109, is being developed as a stand-alone treatment, though it may also be incorporated into their ALVR106 respiratory virus therapy at some point in the future.

Normally, the body would make virus-specific T-cells on their own and these would clear the virus, commented Dr. Melian. We enable that process in patients who otherwise would be T-cell deficient to restore T-cell immunity by giving ex vivo expanded cells that come from patients who already have demonstrated a potent immune response and have cleared the infection.

The process of creating coronavirus-specific T-cells is the same as creating their other virus-specific T-cell therapies. First, blood is taken from people who have recovered from COVID-19 and the T-cells are isolated. Then, the cells are stimulated with viral antigens in the lab, expanded, and cryopreserved.

We purposely choose a broad range of viral antigens to stimulate the T-cells to ensure the virus cant circumvent the virus-specific T-cell therapy by mutating or developing resistance, Dr. Melian said. Working with a wide spectrum of viral activity is different than other approaches that just focus on one viral antigen.

An open-label Phase 1 trial (called BAT IT) is anticipated to start within the next few months. Initial clinical studies of ALVR109 aim to treat high-risk COVID-19 patients, such as the elderly, to prevent organ damage. Prophylaxis studies, where the T-cells could be given to high-risk or immunocompromised patients who are not currently sick with COVID-19, may be considered later.

Coronavirus-specific T-cells vs. COVID-19 convalescent plasma

You may be wondering if another treatment that uses blood from COVID-19 survivors, called convalescent plasma therapy, is similar to AlloVirs T-cell therapy. In convalescent plasma treatment, antibodies from COVID-19 survivors are isolated from their blood by separating out their plasma (the liquid part of the blood). The plasma is given to COVID-19 patients to help their immune system fight off the infection.

Although convalescent plasma and AlloVirs coronavirus-specific T-cell treatments are both derived from COVID-19 survivors blood, the two treatments are fundamentally different.

Antibodies and T-cells work in different areas of the immune system, explained Dr. Melian. Antibodies can go after viruses in circulating blood but cant necessarily see viruses in infected cells. On the other hand, T-cells are pleotropic and directly attack virally infected cells, turning off the viral factories. T-cells are interesting because it is a live therapy they can home to virally-infected cells and direct the immune system.

Dr. Melian went on to explain that T-cell approach may be more comprehensive because they can support other immune cells that work against viruses, such as B-cells that make viral-specific antibodies. T-cells can also stimulate cytokines including interferon (a group of signaling proteins the immune system uses to respond to viruses), which further activates the bodys antiviral response.

Providing virus-specific antibodies may be beneficial and protective for some viral infections, Dr. Melian added. We dont know how these antibodies affect COVID-19 patients yet, but COVID-19 has a high mortality rate despite standard of care treatment. In this respect, it is important that all viable approaches to treatment be evaluated and I am very pleased to see these therapies have entered clinical testing.

Convalescent plasma and AlloVirs coronavirus-specific T-cell therapies are not mutually exclusive, so they could even be used together.

More:
Equipping the Immune System to Fight Against COVID-19 - BioSpace

Recommendation and review posted by Alexandra Lee Anderson

Aytu BioScience Announces Manufacture and Delivery of Healight(TM) Devices for Use in COVID-19 Clinical Study – Yahoo Finance

Delivery of Investigational Endotracheal Ultraviolet-A Light Catheter Devices Enables Near-Term Initiation of Planned Clinical Studies in Severely Ill COVID-19 Patients

ENGLEWOOD, CO / ACCESSWIRE / August 17, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the delivery of Healight investigational devices. The delivery of these pilot scale Healight devices, designed and developed by Sterling Medical Devices ("Sterling"), enables the initiation of COVID-19 investigational clinical studies, which are expected to begin in the near-term.

Since Aytu signed a master services agreement with Sterling in April for Healight, the Company, Sterling, and its collaborators have sourced Healight device components and finalized design of the investigational devices for use in upcoming clinical studies.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "A significant amount of work has gone into the development of the Healight investigational device, and we thank all of our collaborators for their efforts. We are looking forward to taking the next steps and advancing Healight as quickly as possible. As the COVID-19 pandemic continues, the investigation and development of novel potential therapies remains a high priority for numerous companies, and Aytu is proud to be part of this important effort. If Healight demonstrates safety and effectiveness in upcoming, planned studies, we are hopeful it can become an important tool in the COVID-19 fight."

The Healight technology platform employs proprietary methods of administering intermittent ultraviolet (UV) A light via a novel respiratory tract device. Pre-clinical findings indicate the technology's significant impact on reducing a wide range of viral and bacterial loads, including the coronavirus HCoV-229E. Recently published pre-clinical data have been the basis of discussions with the FDA for a path to enable human use for the potential treatment of SARS-CoV-2 in intubated patients in the intensive care unit (ICU). Beyond the initial pursuit of a potential SARS-CoV-2 ICU indication, additional experimental studies of mixed infection suggest broader potential clinical applications for the technology across a range of viral and bacterial pathogens. This may include nosocomial bacteria implicated in ventilator-associated pneumonia (VAP).

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Story continues

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about

About Sterling Medical Devices

Founded in 1998, Sterling Medical Devices (SMD), specializes in the product design and engineering of medical devices for the healthcare industry. Dedicated to resolving their clients' medical device design and engineering challenges, SMD addresses the whole development process, including, product design and human factors, systems, software, electronics, mechanical, quality, compliance, and global regulatory submissions. The company utilizes the latest tools and technology to streamline the engineering process to speed regulatory registrations, clearances, and/or approvals of Class I, II, and III devices. To date, the company has spearheaded the production of over 1,100 projects for more than 300 clients. SMD is internationally recognized and is FDA QSR 21 CFR Part 820 and Part 11 compliant, ISO 13485 registered, and IEC 62304, ISO 14971, IEC 60601, and IEC 62366 compliant. For more information, please visit http://www.sterlingmedicaldevices.com or call 201.227.7569 x2.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, manufacturing, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/601817/Aytu-BioScience-Announces-Manufacture-and-Delivery-of-HealightTM-Devices-for-Use-in-COVID-19-Clinical-Study

More:
Aytu BioScience Announces Manufacture and Delivery of Healight(TM) Devices for Use in COVID-19 Clinical Study - Yahoo Finance

Recommendation and review posted by Alexandra Lee Anderson

Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration – Yahoo Finance

Aytu BioScience's Sublicensee SUDA Pharmaceuticals Secures TGA Approval, Enabling Near-Term Commercialization of ZolpiMist

ENGLEWOOD, CO / ACCESSWIRE / July 30, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the approval of ZolpiMist (zolpidem tartrate oral spray) by the Therapeutic Goods Administration (TGA) in Australia. This approval, which was secured by the Company's ZolpiMist sublicensee SUDA Pharmaceuticals Ltd ("SUDA"), enables near-term commercialization of ZolpiMist in Australia. SUDA (ASX:SUD) is a publicly-listed drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia.

With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and can now be commercialized and supplied within Australia. Further, this approval will assist SUDA's current ZolpiMist sublicensees, Teva Pharmaceuticals, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in their submissions in their respective territories.

On March 9, 2010 Aytu BioScience announced a global distribution agreement for ZolpiMist with SUDA whereby the Company assumed a milestone and royalty-based licensing agreement with SUDA. As specified in the companies' global licensing agreement, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA's sublicensees as ZolpiMist is launched in each territory.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We congratulate the SUDA team for obtaining TGA approval for ZolpiMist and look forward to SUDA and their partners moving ZolpiMist closer to commercialization in Australia and elsewhere. This is an exciting time for SUDA and represents an important milestone for Aytu as we move closer to realizing ex-US licensing revenue for ZolpiMist."

Story continues

Dr. Michael Baker, Chief Executive Officer and Managing Director of SUDA, commented, "The TGA submission was a combined effort by SUDA's technical team as well as our regulatory consultant, Pharma To Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future."

The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.

About Aytu BioScience, Inc.Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX:SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA's product pipeline includes ZolpiMist, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer. For more information, visit http://www.sudapharma.com

Forward-Looking StatementThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, including the risks associated with ZolpiMist's commercial success in Australia and elsewhere, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/599574/Aytu-BioScience-Announces-Regulatory-Approval-of-ZolpiMistR-by-Australian-Therapeutic-Goods-Administration

See the rest here:
Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - Yahoo Finance

Recommendation and review posted by Alexandra Lee Anderson

Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration – BioSpace

Aytu BioScience's Sublicensee SUDA Pharmaceuticals Secures TGA Approval, Enabling Near-Term Commercialization of ZolpiMist

ENGLEWOOD, CO / ACCESSWIRE / July 30, 2020 / Aytu BioScience , Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the approval of ZolpiMist (zolpidem tartrate oral spray) by the Therapeutic Goods Administration (TGA) in Australia. This approval, which was secured by the Company's ZolpiMist sublicensee SUDA Pharmaceuticals Ltd ("SUDA"), enables near-term commercialization of ZolpiMist in Australia. SUDA (ASX:SUD) is a publicly-listed drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia.

With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and can now be commercialized and supplied within Australia. Further, this approval will assist SUDA's current ZolpiMist sublicensees, Teva Pharmaceuticals, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in their submissions in their respective territories.

On March 9, 2010 Aytu BioScience announced a global distribution agreement for ZolpiMist with SUDA whereby the Company assumed a milestone and royalty-based licensing agreement with SUDA. As specified in the companies' global licensing agreement, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA's sublicensees as ZolpiMist is launched in each territory.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We congratulate the SUDA team for obtaining TGA approval for ZolpiMist and look forward to SUDA and their partners moving ZolpiMist closer to commercialization in Australia and elsewhere. This is an exciting time for SUDA and represents an important milestone for Aytu as we move closer to realizing ex-US licensing revenue for ZolpiMist."

Dr. Michael Baker, Chief Executive Officer and Managing Director of SUDA, commented, "The TGA submission was a combined effort by SUDA's technical team as well as our regulatory consultant, Pharma To Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future."

The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.

About Aytu BioScience, Inc.Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX:SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA's product pipeline includes ZolpiMist, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer. For more information, visit http://www.sudapharma.com

Forward-Looking StatementThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, including the risks associated with ZolpiMist's commercial success in Australia and elsewhere, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com:https://www.accesswire.com/599574/Aytu-BioScience-Announces-Regulatory-Approval-of-ZolpiMistR-by-Australian-Therapeutic-Goods-Administration

See more here:
Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - BioSpace

Recommendation and review posted by Alexandra Lee Anderson

Maybe its low testosterone? – The Durango Herald

As we age, we tend to see dips in testosterone.

This isnt ideal as testosterone is a key hormone in keeping both men AND women at optimal health with high energy, supple skin, good muscle mass and the ability to build it, strong sex drive, and the ability to cope with stress (a big one for the times we are currently in).

So, how do we keep our testosterone levels at their peak as we age?

Drop excess body fat, especially the stuff around the belly. You can better bet that if you are sporting a beer belly or just seem to carry your fat in your midsection that your testosterone is lower than it should be. In men, this belly fat actually secretes hormones (aromatase) that help to convert the testosterone you do make into estrogen. Those low T and higher estrogen levels help the body continue to easily gain more fat that sticks primarily to your belly, chest, and throat area. For men, dropping this fat will allow for the most significant improvements in your testosterone levels than all of the other following suggestions.Move, but watch how you do it. The body doesnt like chronic cardio. By this I mean long stints on the bike, endurance runs by the river, or tedious bouts on the elliptical or rowing machine. This drags on the body, just like it does on the joints, and the body responds with a drop in testosterone among other things. What the body loves hormonally, is explosive resistance training and some high-intensity interval training. A few days a week, lift something heavy, not so heavy that youll injure yourself, but heavy enough that it overloads your muscles a bit. To get the most bang for your buck, make sure to work the bigger muscles groups (think legs) and body parts that carry a high density of androgen receptor sites (shoulders and chest). Dead lifts (avoid if you have low back pain) and squats are some of the best testosterone producing movements out there.

The days when you arent lifting, do some HIIT. Though HIIT might not sound appealing, the great thing about it is that the sessions are short and sweet. Lets use the stationary bike as an example. Warm up for 5 minutes, increase resistance or speed for 45 seconds so that you are breathing hard, then rest easy for 90 seconds. Repeat this on/off cycle about 10 to 12 times if you can and cool down. The entire HIIT session should only take about 20 to 25 minutes. And as always, consult your doctor before starting any new exercise routine.

Make sure you arent deficient in vitamins and minerals. Eat a whole-foods, nutrient-dense diet, dont skimp on dietary fats, and get plenty of vitamin D by spending time in the sun. You might also consider supplementing with boron, iodine, selenium, magnesium, and a B vitamin complex. If you do supplement, ask your doctor before taking any new supplements.Manage your stress and cultivate meaningful relationships. This might not seem like a big deal, but it is. High stress and lack of companionship decrease testosterone. Think self-care practices such as prayer/intention setting, time in nature, meditation, journaling or practicing gratitude a combination would be best! Building connection through relationships definitely takes effort but its worth it and your body will thank you.Prioritize sleep. This is a big one! The majority of daily testosterone secretions occur during sleep. Poor sleep (because of restlessness, not enough hours or sleep apnea, for instance) is associated with reduced testosterone in both men and women. A study published in the Journal of the American Medical Association found that one week of short sleep (5 hours per night) reduces testosterone production by 10% to 15%.There you have it! Five steps to start taking your health (and your hormones) into your own hands. Make the decision to take control of your body and say NO to low energy, poor mood, and suboptimal living.

Ashley Lucas holds a Ph.D. in sports nutrition and chronic disease and is a licensed, registered dietitian. She is the founder and owner of Ph.D. Weight Loss and Nutrition, offering in-office and at-home/virtual weight management and wellness services in the Four Corners. To contact her, visit http://www.myphdweightloss.com or call 764-4133.

Link:
Maybe its low testosterone? - The Durango Herald

Recommendation and review posted by Alexandra Lee Anderson

Low Testosterone: Symptoms, Diagnosis & Treatment …

What is Testosterone?

Testosterone is the male sex hormone that is made in the testicles. Testosterone hormone levels are important to normal male sexual development and functions.

During puberty (in the teen years), testosterone helps boys develop male features like body and facial hair, deeper voice, and muscle strength. Men need testosterone to make sperm. Testosterone levels generally decrease with age, so older men tend to have low blood testosterone levels.

Some men have low testosterone levels. This is called testosterone deficiency (TD) or often referred to as Low Testosterone (Low-T).

The American Urology Association (AUA) identifies low blood testosterone (Low-T) as less than 300 nanograms per deciliter (ng/dL) on two tests obtained in the morning. Several symptoms or conditions may accompany TD:

You may benefit from testosterone therapy (TT) if you have TD and bothersome symptoms (described above). In some cases, TT is strongly recommended, such as with certain conditions you are born with (i.e. Klinefelter syndrome) or if the testicles are removed or lost due to surgery, trauma, infection, or other similar issues. The FDA has approved TT as a replacement for men with low T due to disorders of the testicles, pituitary gland, or brain which result in low T.

Although the use of TT in men with declining T levels due to aging or other conditions is not specifically approved by the FDA, it is commonly prescribed for these conditions "off-label." Speak with your physician to determine if you may benefit from TT, including which type of treatment is most appropriate.

TT may help you but it is also linked to certain (potentially harmful) side effects. (See discussion of these side effects below.) Some of these side effects are definitely linked to TT, while others remain debatable. One area of ongoing debate is whether TT may increase the risk for heart disease or stroke in certain men.

Based on data from a few clinical studies, the Federal Drug Administration (FDA) required that testosterone drug labels should state that there is a risk for heart disease and stroke for some men using testosterone products. All men should be checked for heart disease and stroke before, and periodically while on, TT. The AUA however, on careful review of evidence-based peer review literature, has stated that at the current time, it is not clear if TT increases or decreases the risk for cardiovascular events, such as cardiovascular disease or strokes.

It is hard to know how many men among us have low T, although data suggest that overall about 2.1% (about 2 men in every 100) may have low T. As few as 1% of younger men may have low T, while as many as 50% of men over 80 years old may have low T. People who study the condition often use different cut-off points for the numbers, so you may hear different numbers being stated.

Low T is more common in men who have diabetes or who are overweight. In one research study, 30% of overweight men had low T, compared to only 6.4% of those with normal weight. The same study found diabetes to be a risk factor for low T. In another study, 24.5% of men with diabetes had low T, compared to 12.6% of those without diabetes.

Read this article:
Low Testosterone: Symptoms, Diagnosis & Treatment ...

Recommendation and review posted by Alexandra Lee Anderson

New Osteoporosis Recommendations From AACE Help Therapy Selection – Medscape

Recommendations on use of the new dual-action anabolic agent romosozumab (Evenity, Amgen)and how to safely transition between osteoporosis agents are two of the issues addressed in the latest clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis from the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE).

"This guideline is a practical tool for endocrinologists, physicians in general, regulatory bodies, health-related organizations, and interested laypersons regarding the diagnosis, evaluation, and treatment of postmenopausal osteoporosis," the authors say.

The guidelines focus on 12 key clinical questions related to postmenopausal osteoporosis, with 52 specific recommendations, each graded according to the level of evidence.

They also include a treatment algorithm to help guide choice of therapy.

Among key updates is an emphasis on the role of the Fracture Risk Assessment Tool (FRAX) in the diagnosis of osteoporosis in patients with osteopenia.

While patients have traditionally been diagnosed with osteoporosis based on the presence of low bone mineral density (BMD) in the absence of fracture, the updated guidelines indicate that osteoporosis may be diagnosed in patients with osteopenia and an increased fracture risk using FRAX.

"The use of FRAX and osteopenia to diagnosis osteoporosis was first proposed by the National Bone Health Alliance years ago, and in the 2016 guideline, we agreed with it," Pauline M. Camacho, MD, co-chair of the guidelines task force, told Medscape Medical News.

"We reiterate in the 2020 guideline that we feel this is a valid diagnostic criteria," said Camacho, professor of medicine and director of the Osteoporosis and Metabolic Bone Disease Center, Loyola University, in Maywood, Illinois.

"It makes sense because when the thresholds are met by FRAX in patients with osteopenia, treatment is recommended. Therefore, why would they not fulfill treatment criteria for diagnosing osteoporosis?"

An increased risk of fracture based on a FRAX score may also be used to determine pharmacologic therapy, as can other traditional factors such as a low T-score or a fragility fracture, the guidelines state.

Another key update is the clarification of the risk stratification of patients who are high risk versus very high risk, which is key in determining the initial choice of agents and duration of therapy.

Specifically, patients should be consideredat a very high fracture risk if they have the following criteria: a recent fracture (eg, within the past 12 months), fractures while on approved osteoporosis therapy, multiple fractures, fractures while on drugs causing skeletal harm (eg, long-term glucocorticoids), very low T-score (eg, less than 3.0), a high risk for falls or history of injurious falls, and a very high fracture probability by FRAX (eg, major osteoporosis fracture > 30%, hip fracture > 4.5%) or other validated fracture risk algorithm.

Meanwhile, patients should be considered at high risk if they have been diagnosed with osteoporosis but do not meet the criteria for very high fracture risk.

Another important update provides information on the role of one of the newest osteoporosis agents on the market, the anabolic drug romosozumab, a monoclonal antibody directed against sclerostin.

The drug's approval by the US Food and Drug Administration (FDA) in 2019 for postmenopausal women at high risk of fracture was based on two large trials that showed dramatic increases in bone density through modeling as well as remodeling.

Those studies specifically showed significant reductions in radiographic vertebral fractures with romosozumab compared to placebo and alendronate.

Camacho noted that romosozumab "will likely be for the very high risk group and those who have maxed out on teriparatide or abaloparatide."

Romosozumab can safely be used in patients with prior radiation exposure, the guidelines note.

Importantly, due to reports of a higher risk of serious cardiovascular events with romosozumab compared to alendronate, romosozumab comes with a black box warning that it should not be used in patients at high risk for cardiovascular events or who have had a recent myocardial infarction or stroke.

"Unfortunately, the very high risk group is often the older patients,"Camacho notes.

"The drug should not be given if there is a history of myocardial infarction or stroke in the past year," she emphasized. "Clinical judgement is needed to decide who is at risk for cardiovascular complications."

Notably, teriparatide and abaloparatide have black box warnings of their own regardingrisk for osteosarcoma.

Reflecting the evolving data on osteoporosis drug holidays, the guidelines also address the issue and the clinical challenges of switching therapies.

"In 2016, we said drug holidays are not recommended, and the treatment can be continued indefinitely, [however] in 2020, we felt that if some patients are no longer high risk, they can be transitioned off the drug," Camacho said.

For teriparatide and abaloparatide, the FDA recommends treatment be limited to no more than 2 years, and for romosozumab, 1 year.

The updated guidelines recommend that upon discontinuation of an anabolic agent (eg, abaloparatide, romosozumab, or teriparatide), a switch to therapy with an antiresorptive agent, such as denosumab or bisphosphonates, should be implemented to prevent loss of BMD and fracture efficacy.

Discontinuation of denosumab, however, can have notably negative effects. Clinical trials show rapid decreases in BMD when denosumab treatment is stopped after 2 or 8 years, as well as rapid loss of protection from vertebral fractures.

Therefore, if denosumab is going to be discontinued, there should be a proper transition to an antiresorptive agent for a limited time, such as one infusion of the bisphosphonate zoledronate.

The authors underscore that in addition to communicating the potential risk and expected benefits of osteoporosis treatments, clinicians should make sure patients fully appreciate the risk of fractures and their consequences, such as pain, disability, loss of independence, and death, when no treatment is given.

"It is incumbent on the clinician to provide this information to each patient in a manner that is fully understood, and it is equally important to learn from the patient about cultural beliefs, previous treatment experiences, fears, and concerns," they write.

And in estimating patients' fracture risk, T-score must be combined with clinical risk factors, particularly advanced age and previous fracture, and clinicians should recognize that the absolute fracture risk is more useful than a risk ratio in developing treatment plans.

"Treatment recommendations may be quite different; an early postmenopausal woman with a T-score of 2.5 has osteoporosis, although fracture risk is much lower than an 80-year-old woman with the same T-score," the authors explain.

Camacho has reported financial relationships with Amgen and Shire. Disclosures for other task force members are detailed in the guidelines.

AACE/ACE Guidelines 2020 Update. Full text

Follow Medscape on Facebook, Twitter, Instagram, and YouTube.

See original here:
New Osteoporosis Recommendations From AACE Help Therapy Selection - Medscape

Recommendation and review posted by Alexandra Lee Anderson

Hormone therapy no cure-all for ‘low T’ in ageing men – Health24

__________________________________________________________________________________________

Testosterone therapy ads promise to help ageing men recapture their vitality, decrease body fat and enhance libido. But hormone treatments while medically necessary for some men aren't meant to be a fountain of youth, and experts warn more research is needed to determine if such therapy could boost heart disease risks.

Testosterone levels naturally decline in most men as they age. This decline is generally mild, and symptoms often are non-specific, such as low energy, reduced muscle mass and reduced vigour. Roughly 20% of men over the age of 60 have experienced a drop in testosterone levels, though this gradual decline can begin as early as the mid-30s.

While that can be frustrating, experts say it's not a clinical indication of a need for testosterone therapy, nor is there any evidence that therapy is effective for treating those symptoms. The Food and Drug Administration (FDA) has limited approval of testosterone therapy to the treatment of organic hypogonadism, a dramatic drop in testosterone caused by disease or injury of the hypothalamus, pituitary gland or the testes.

"If testosterone therapy is used appropriately in men with organic hypogonadism, then there is no controversy," said Dr Shehzad Basaria, associate director of Men's Health: Aging and Metabolism at Brigham and Women's Hospital in Boston. The condition causes specific symptoms such as decreased sexual desire, breast enlargement, testicular atrophy and hot flashes.

Potentially harmful use

But "in middle-aged and ageing men who have a slightly lower testosterone level and non-specific symptoms due to ageing or obesity, testosterone therapy is not indicated. Similarly, testosterone is not a rejuvenation drug," said Basaria, an associate professor of medicine at Harvard Medical School. "The majority of patients seen in our clinics have symptoms such as fatigue, weight gain, muscle loss or feeling sad. These symptoms are common and non-specific, and testosterone therapy is generally not indicated in such clinical scenarios."

Over the past two decades, intense direct-to-consumer marketing of hormone therapy for ageing men, much of it via television ads, has more than doubled its off-label use. It's a trend experts warn is medically unwarranted and potentially harmful.

The American College of Physicians, which issued new guidelines in January, recommends against prescribing testosterone therapy to boost energy, vitality or physical function, but supports its use for men experiencing sexual dysfunction. The recommendation calls for discussing potential benefits and risks with the patient and discontinuing treatment after one year if there is no improvement.

"I think one of the biggest concerns about testosterone therapy is whether it is really needed," said Dr Robert Eckel, professor of medicine and an endocrinologist at the University of Colorado School of Medicine in Aurora, Colorado. "Erectile dysfunction is a common problem as men age, but there can be other reasons for this, such as vascular disease or nerve damage, which is more common in patients with diabetes. It is not necessarily an indication for treatment with testosterone therapy. The patient must be properly evaluated."

Higher cardiovascular risk

The FDA warns against prescribing testosterone therapy for age-related hormonal decreases or anything other than a medical diagnosis of hypogonadism. Since 2015, it has required testosterone product labels to warn of a possible increased risk of heart attacks and stroke.

But research about that association so far is unclear, Basaria said.

"Some studies have reported higher cardiovascular risk with testosterone use but there are an equal number of studies showing that it does not increase cardiovascular risk," he said. "This discrepancy exists because no study published to date has been powered to assess cardiovascular events as the primary outcome."

Eckel, president of medicine and science for the American Diabetes Association and a past president of the American Heart Association, agreed. "The cardiovascular disease outcome story is not convincing one way or another. I think to make a strong statement here would be a mistake."

Image credit: iStock

View original post here:
Hormone therapy no cure-all for 'low T' in ageing men - Health24

Recommendation and review posted by Alexandra Lee Anderson

Low Testosterone (Low T): Causes, Symptoms, Diagnosis …

What is low testosterone (male hypogonadism)?

Low testosterone (male hypogonadism) is a condition in which the testes (testicles, the male reproductive glands) do not produce enough testosterone (a male sex hormone).

In men, testosterone helps maintain and develop:

Low testosterone affects almost 40% of men aged 45 and older. It is difficult to define normal testosterone levels, because levels vary throughout the day and are affected by body mass index (BMI), nutrition, alcohol consumption, certain medications, age and illness.

As a man ages, the amount of testosterone in his body gradually drops. This natural decline starts after age 30 and continues (about 1% per year) throughout his life.

There are many other potential causes of low testosterone, including the following:

Symptoms of low testosterone depend on the age of person, and include the following:

Other changes that occur with low testosterone include:

Last reviewed by a Cleveland Clinic medical professional on 04/10/2018.

Get useful, helpful and relevant health + wellness information

Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. Policy

Read more from the original source:
Low Testosterone (Low T): Causes, Symptoms, Diagnosis ...

Recommendation and review posted by Alexandra Lee Anderson


Page 11234..1020..»