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Category : Testosterone Physicians

Jury Punishes AbbVie for False Advertising in First MDL Verdict – Legal Examiner

In June of 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed testosterone-replacement therapy (TRT) lawsuits into one court in the Northern District of Illinois. District Judge Matthew Kelley decided early on that trials would be scheduled based on the type of TRT product used. Since AbbVies product AndroGel leads the market in testosterone-replacement products, the first bellwether trials each involve AndroGel.

In the second case to be tried, a Chicago jury determined that manufacturer AbbVie should pay $150 million to an Oregon man who suffered a heart attack after taking the drug.

The plaintiff first started taking AndroGel in 2008, and used it through 2012. He suffered a heart attack that year, at 49 years old. He claimed that AbbVie failed to warn of the risks associated with their drug, which he claims include blood clots, heart attacks, and strokes. He also claimed that the company misled consumers when they aggressively advertised the drug as a solution for age-related low-T.

The jury came back with a split verdict. They awarded the plaintiff $150 in punitive damages, stating that AbbVie was liable for false marketing and fraudulent misrepresentation. At the same time, however, they concluded that the plaintiffs heart attack was not caused by AbbVies negligence, and did not award him any compensatory damages.

AbbVie blamed the plaintiffs heart attack on other risk factors, including high blood pressure and cholesterol, obesity, and smoking. The company is expected to appeal the verdict.

This is only the second of seven planned bellwether trials to go to a jury. (An earlier trial ended in a mistrial, and is expected to begin again in September.) The consolidated litigation includes about 4,000 lawsuits, with all plaintiffs claiming that the manufacturers failed to warn of cardiovascular and blood-clot-related risks.

Even if the verdict doesnt stand, it sends a powerful message to AbbVie, and shows that juries will likely react unfavorably to AbbVies aggressive million-dollar advertising campaign. The company marketed the drug as an effective treatment for low-T, which it described as a condition with the same symptoms of normal male aging, like fatigue, muscle loss, and drop in libido.

The FDA, however, approved testosterone replacement only for medically diagnosed low testosterone, or hypogonadism. Studies have shown that many of the men who were convinced to take the drug never had a single testosterone test to diagnose any medical condition.

In 2014, for example, researchers reported that 40.2 percent of U.S. men did not have a testosterone test in the 180 days before beginning therapy, and 50 percent had only one test (doctors usually conduct at least two to get an average reading).

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Jury Punishes AbbVie for False Advertising in First MDL Verdict – Legal Examiner

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Australian Market Declines – Nasdaq

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( – The Australian stock market is declining on Wednesday following the weak lead overnight from Wall Street amid heightened geopolitical tensions after North Korea’s nuclear missile test on Sunday.

In late-morning trades, the benchmark S&P/ASX 200 Index is down 25.60 points or 0.45 percent to 5,680.60, off a low of 5,662.70 earlier. The broader All Ordinaries Index is declining 24.70 points or 0.43 percent to 5,743.10.

In the banking sector, ANZ Banking, Westpac, Commonwealth Bank and National Australia Bank are lower in a range of 0.9 percent to 1.4 percent.

Gold miners are advancing after gold prices rallied overnight. Newcrest Mining is advancing 1 percent and Evolution Mining is rising more than 2 percent.

Oil stocks are also higher after crude oil prices rose almost 3 percent overnight. Woodside Petroleum is adding 0.3 percent, Oil Search is advancing almost 1 percent and Santos is rising almost 2 percent.

AGL Energy said it has made no commitment to sell its Liddell coal-fired power station in NSW nor extend its life beyond 2022. The energy producer’s shares are declining almost 1 percent.

Acrux and pharma giant Eli Lilly have agreed to terminate their licensing deal for Axiron, a testosterone replacement therapy for men. Shares of Acrux are losing almost 23 percent.

On the economic front, Australia will release second-quarter numbers for its gross domestic product or GDP today.

In the currency market, the Australian dollar is higher against the U.S. dollar on Wednesday after the greenback fell following the release of weak U.S. durable goods data. In early trades, the local unit was trading at US$0.7995, up from US$0.7975 on Tuesday.

On Wall Street, stocks closed sharply lower on Tuesday, partly reflecting geopolitical concerns following news North Korea conducted a major nuclear test on Sunday. Traders also kept an eye on any developments in Washington, as lawmakers returned following the August recess.

The Dow plunged 234.25 points or 1.1 percent to 21,753.31, the Nasdaq tumbled 59.76 points or 0.9 percent to 6,375.57 and the S&P 500 slumped 18.70 points or 0.8 percent to 2,457.85.

The major European markets ended mixed on Tuesday. While the German DAX Index rose by 0.2 percent, the French CAC 40 Index dipped by 0.3 percent and the U.K.’s FTSE 100 Index fell by 0.5 percent.

Crude oil futures touched the highest in four weeks Tuesday, supported by a stronger dollar and concerns about rigs in the Gulf of Mexico. October WTI oil climbed $1.37 or 2.9 percent to settle at $48.66 a barrel on the New York Mercantile Exchange, the highest since August 11.

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Australian Market Declines – Nasdaq

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Choosing Wisely: Aytu BioScience vs. Lipocine – –

Both Aytu BioScience (AYTUD) and Lipocine Inc. (NASDAQ:LPCN) are advancing novel testosterone replacement therapies, but when placed side by side, which stock may make investors pumped for joy?

The testosterone replacement therapy market is a hot sector with companies focused on grabbing as much of the estimated $2 billion market as they can. Two emerging companies, in particular, are focused on delivering shareholders both near- and long-term value propositions by advancing their unique TRT products, one of which has recently hit the market. While several large pharmaceuticals are well entrenched in the TRT market already, their products, like AbbVie’s (NYSE:ABBV) AndroGel, Eli Lilly’s (NYSE:LLY) Axiron and Endo International’s (NASDAQ:ENDP) Fortesta, are plagued with the most severe of Food and Drug Administration (FDA) warnings the dreaded Black Box warning. Thus, with the market opportunity open to treatments that may provide a better solution without the known risks of currently marketed TRT products, let’s place two peer competitors side by side to determine the chances of either taking a bite out of the current market potential.

Is Aytu BioScience the ‘wise choice?’

Although Aytu BioScience experienced a tough month in August, likely attributable to the recent capital raise, the company has never been stronger from a clinical and marketing perspective. Now that the split is old news and with shares trading above $3.70, the distractions of the past month may soon get replaced with investor optimism about the company’s lead TRT product, Natesto.

Natesto has the potential to become a game changer in the TRT market. Although Aytu is marketing with a much smaller budget than those with already approved therapies on the market, at some point investors believe that wisdom will soon replace big pharma muscle, making Natesto the TRT of choice for prescribing physicians. And, when looking at published clinical data, the case for a market-leading Natesto should not be cast off as pure fodder. In fact, when comparing Natesto to Lipocine’s pipeline TRT, Tlando, as well as to a host of other big-name drugs, Natesto has demonstrated statistically better efficacy and appears to be a safer and more effective treatment than most TRT products currently on the market.

Keeping the focus only on both companies’ TRT products, other promising Aytu pipeline products won’t get considered. Investors should not discount the value inherent to the Aytu pipeline consisting of a male infertility product MiOXSYS and a female sexual wellness product Fiera that like Natesto may offer significant and compelling market advantages. OK, so what about Natesto’s bid to be best in class?

First off, Natesto is the only nasally administered TRT on the market. And, while some investors may not understand the significance of that issue, users of the product will. Being nasally administered helps to alleviate inadvertent transfer of testosterone, provides consistent and efficient dosing and offers significant convenience over topically applied products. Because of these advantages, Natesto is the only currently marketed FDA-approved topical TRT product not labeled with the severe FDA-required Black Box warning. Those safety and convenience issues are just the tip of the iceberg in the advantages column; there is more to Natesto to justify its place in the $2 billion TRT market.

It’s no accident that Natesto has been called the potential best-in-class therapy on the market. Coming off its recent spike of over 300% in new prescription volume, Natesto is grabbing the attention of physicians due to the proven effectiveness of the product, which also leaves behind the severe side effects for patients. The differentiating factors are apparent; Natesto reduces or eliminates the potential for accidental transfer and does not require a man taking the product to quarantine himself from a female or child while the product is applied.

Additionally, being a hands-free application, Natesto offers consistent dosing in a measured treatment, and that’s an important issue since excessive intake of testosterone is not necessarily a good thing for patients. Of perhaps greater importance, though, is that Natesto does not significantly reduce levels of LH and FSH hormones in the body, which has caused side effects in patients (including reducing sperm count and decreasing testicle size) who use products like AndroGel, Axiron, Fortesta and injectable products. Not only does Natesto maintain proper hormone levels in patients, but it also eliminates the potential for users getting hooked on testosterone treatments to maintain healthy testosterone levels. Natesto excels in other areas of concern as well, demonstrating a better safety profile over long-acting gels and injections that have been shown to increase hematocrit concentrations in the patient. That is, the treatments make the patient’s blood thicker, which may lead to stroke and cardiac-related complications in patients. From a safety perspective, Natesto is best in class, but what about the efficacy?

The safety profile is significant, but it’s how Natesto performs that is the real story. Marketed as “testosterone in seconds,” Natesto is now the first and only FDA-approved intranasal TRT on the market. In a clinical trial, the majority of patients achieved statistically significant improvement in each of the five domains of erectile function. In most cases, the effect on normalizing erectile function occurred within the first 30 days of treatment. In addition to the benefits mentioned, 70% of men in the Natesto pivotal trial said they would switch from their current TRT to treatment with Natesto. Thus, no surprise that Natesto has seen a sharp trend higher in new prescription rates, with new authorizations for the product doubling since May. Also, 90% of men taking Natesto get their testosterone levels back to “normal,” which is higher than other TRTs. And most men taking Natesto see their moods improve as soon as 30 days from starting treatment. The market is estimated to stand at approximately $2 billion currently, and if Aytu maintains the current trend, even a 10% market penetration can return over $200 million in new revenues.

Now that Aytu has roughly only 4 million shares outstanding, a revenue spike of that magnitude would most likely cause a disproportionate rise in company market cap, which currently reflects anemic value considering this potentially game-changing product. Adding in the potential of Aytu’s other marketed products, the company may be a very wise choice for investors seeking long-term value and probability for share price appreciation.

Is Lipocine the ‘wise choice?’

Lipocince is developing a testosterone product called Tlando. Although the product is not yet on the market, Lipocine is the closest peer to Aytu from a market perspective. Lipocine is taking a different approach for Tlando, testing an orally administered dose of testosterone, which the company plans to submit to the FDA for approval in the coming months. Investors need to know that the FDA has already denied the application for Tlando once, but Lipocine is preparing to try for approval once again, relying on similar data from the original rejected application.

A potential drawback for the oral administration of Tlando is that patients will be required to keep a consistent diet, maintaining certain fat content and calorie intake. And this is the case for each dosing. If patients fail to adhere to specific dietary requirements, patients are unlikely to see a meaningful rise in testosterone levels, which would be a huge problem and a potential marketing nightmare for the product. A significantly more adverse scenario is that during the company’s FDA studies, a handful of men reached testosterone levels of over 2500 ng/dl, which is both extremely high and dangerous.

In addition to potential FDA problems looming for Tlando, the company itself said in a press release that LPCN 1021 (Tlando) only “generally met” the prespecified per dose secondary endpoints for twice daily oral administration. In layman’s terms, the product either meets the endpoint or it doesn’t, and when the company itself publishes mixed messages, investors should pay close attention. Also important to note is that the FDA will be highly unappeased if men being treated by Tlando exceed the 2500 ng/dl level, making the chances for approval unlikely. And to add insult to potential misery, as far as the FDA is concerned, when endpoints are “generally met,” product support is unlikely. The FDA’s words, not mine.

The biggest issue for Tlando compared to Natesto, though, is that when placed side by side, Tlando does not get as many men to normal testosterone levels. Company-sponsored studies demonstrate a significant edge in benefit from Natesto with 90% of males reaching normal testosterone levels, compared to just 70% of patients reaching normal testosterone levels when using Tlando. The FDA has made it known that at least 75% of men taking the testosterone product must reach normal T levels so it is difficult to understand how the FDA would even approve Tlando. Additionally, with Tlando known to produce dangerously high testosterone concentrations in some men, the road to approval may be far tougher than even the most optimistic investor may be willing to admit.

The ‘wisest choice?’

Comparing the two, Aytu emerges as a clear “wise choice” for investors wanting exposure to the multibillion-dollar TRT market. Interestingly, Lipocine has a current market cap of roughly $75 million compared to Aytu’s approximately $15 million market cap. From both a product and valuation standpoint, the opportunity for growth is substantial in the Aytu BioScience camp, particularly when you consider that there is no regulatory risk for Aytu. The product is already on the market and growing rapidly. Although a slim chance exists for approval for Tlando, the product would most likely be met with considerable marketing difficulties. Conversely, with Aytu’s Natesto already approved and marketed, the promise again lay squarely in the Aytu potential.

Now that the TRT comparisons are noted, it’s fair to factor in both Aytu’s and Lipocine’s additional pipeline opportunities. While a slight opportunity may have existed for Lipocine to present itself in a better light, the company is yet to produce an impressive clinical statistic. Thus, the clear advantages still weigh heavily in Aytu’s favor, solidifying its position as the better of the two. With a pipeline focused on making use of a combined market opportunity of more than $11 million in the bank following its recent capital raise, in this case, Aytu BioScience is the superior choice for investors looking to “choose wisely.”

This article was originally featured on CNA Finance.

Disclosure: The author has no positions in any stock mentioned in this article.

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Choosing Wisely: Aytu BioScience vs. Lipocine – –

Recommendation and review posted by Alexandra Lee Anderson

Biotech’s shares plummet as US deal ends | SBS News – SBS

Shares in biotech Acrux have plummeted after Acrux and US-based pharmaceutical giant Eli Lilly and Co agreed to end their licensing deal for Axiron, a testosterone replacement therapy for men.

Axiron was the first testosterone replacement product that could be applied like a roll-on deodorant on the armpit of a patient.

Melbourne-based Acrux secured a licensing deal with Eli Lilly in 2010, which Acrux described at the time as one of the largest, if not the largest, licensing deals undertaken by an Australian biotech company.

Under the deal, Acrux could receive up to $US335 million plus royalties from Eli Lilly in return for exclusive rights to commercialise Axiron.

“Termination of the license in the US is effective immediately and termination of license outside the US will be effective 90 days thereafter,” Acrux said in a statement on Wednesday.

“Global rights to the product will revert to Acrux.”

Shares in Acrux dropped 7.5 cents, or 28 per cent, to 19 cents, reducing the company’s market value by $12.5 million.

Acrux said generic treatments for testosterone deficiency were creating commercial uncertainty, and the testosterone market was declining.

The costs of a clinical trial required by the US Food and Drug Administration to determine whether an increased risk of heart attack or stroke exists among users of testosterone were also uncertain, the company said.

Acrux is also appealing a US court decision that held that patents for the Axiron formulation were invalid.

Generic versions of Axiron were launched in the US by pharmaceutical firms Perrigo and Teva in July and August.

Eli Lilly and Prasco also launched an authorised generic version of Axiron, from which Acrux received royalties on sales.

Acrux said it is committed to asserting its intellectual property rights for Axiron and the court appeal on the patents issue will continue.

Eli Lilly’s global sales in the year to June 30 of $US143 million was down from $US149.3 million in the prior year.

Acrux’s royalty revenue from Axiron fell 10 per cent to $A22.8 million in 2016/17, refelecting the decline in global sales.

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Biotech’s shares plummet as US deal ends | SBS News – SBS

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Does propecia work in owmen – How long before propecia works – Testosterone replacement therapy and propecia – Twin Cities Arts Reader

Adam Jacobs (Aladdin) and Isabelle McCalla (Jasmine) star in the national touring production of Aladdin. Photo by Deen van Meer.How many people does it take to put on a national tour of a Broadway show? If the show isAladdin, the answer is 75…if you only count the people who show

The Catalyst Quartet rehearsing.It was the first of August. Dr. Deborah Justice was settling in for a month of fiddling around musically speaking when the email arrived. “Im afraid I have some sad news from Caracas,” it began. “Venezuela at this moment is now a war zone.”At that

The late J. Otis Powell.Poet, playwright, and overall multi-talented artist J. Otis Powell died on Monday, August 28. Powell was 61 years’ old, and had been awarded a Sally Ordway Irvine Award for Commitment just five days prior. He had struggled with ill health, and received a kidney transplant several

A bar chart showing historical box office totals for the Minnesota Fringe Festival.The Minnesota Fringe Festival announced the final statistics today for the 2017 Minnesota Fringe Festival. The 11-day festival brought in 46,076 butts-in-seats, spread across 860 performances of 167 shows at 17 venues in Minneapolis.Why Count Butts-in-Seats?Since 2016, the

The Ordway Center for the Performing Arts announced today the recipients of the 25th annual Sally Ordway Irvine Awards. These awards were given in five categories to recipients from across the State of Minnesota. This year’s recipients are all based in the Twin Cities metro area: Hunter Gullickson (Arts Access)

Actors Gary Briggle (left) and Wendy Lehr (right). Photo by Keith Bridges.The playwright A.R. Gurney passed away two months ago. Many of the various eulogies and obituaries cited his 1988 playLove Letters, a tale of charmed correspondence that was nominated for a Pulitzer Prize.Love Letters encapsulated many of the themes

Lady Gaga rocked the Xcel Energy Center with her trademark costume-heavy, immersive performance. Here’s the set list from the concert:Act I “Video Intro” “Diamond Heart” “A-Yo” “Poker Face” “Perfect Illusion”Act II “John Wayne” “Scheie” “Alejandro”Act III “Horns” “Just Dance” “LoveGame” “Telephone”Act IV “Claws” “Applause” “Come to Mama” “The Edge of

A mosaic of different graphs of Fringe Festival sold-out attendance data.It’s been one week since the 2017 Minnesota Fringe Festival closed its doors and the Fringe staff are still tallying and double-checking festival data. While a fuller report on the festival box office is still forthcoming, here are six figures

Women dancing inArabian Nights.Photo by Dan Van Meer.The Orpheum Theatre is getting a magic lamp. Starting September 15, the Orpheum will host the Broadway touring production of Aladdin for three and a half weeks (closing October 8). This touring production stars Adam Jacobs, who originated the title role of Aladdin

Actress-musician-songwriter Claire Wellin. Photo by Tiffany Topol.This Friday, Claire Wellin is bringing her band Youth in a Roman Field to Icehouse in Minneapolis. Youth in a Roman Field’s “ghost folk” sound emphasizes haunting strings, acoustic instruments, and multipart vocal writing. The MSU-Mankato graduate spoke with the Arts Reader’sBasil Considine about

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Does propecia work in owmen – How long before propecia works – Testosterone replacement therapy and propecia – Twin Cities Arts Reader

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Testosterone replacement therapy associated with improved urinary, sexual function – ProHealth

Reprinted with the kind permission of Life Extension.

August 23 2017.An article appearing on July 18, 2017 in theJournal of Urologydocuments improvements in sexual function, urinary function and quality of life among men who receivedtestosterone replacement therapy.

The prospective registry study involved 656 men with low testosterone levels and symptoms of testosterone deficiency, among whom 360 were regularly treated with parenteral testosterone undecanoate for up to 10 years. The remainder of the subjects, who chose not to be treated with testosterone, received biannual routine clinic visits.

The researchers, from Boston University School of Medicine and School of Public Health in collaboration with German urologists, found that men who received testosterone therapy experienced significant decreases in their International Prostate Symptom Score, post-voiding bladder volume and Aging Males Symptoms scale, which assesses health-related quality of life. The percentage of patients without erectile dysfunction significantly improved in the testosterone treated group, from 17.1% at the beginning of the study, to 74.4% of the study at the last visit. In contrast, subjects who did not receive the hormone experienced deterioration in erectile function as well as in voiding functions. Prostate specific antigen (PSA), a marker which, when elevated, is associated with an increased risk of prostate cancer, remained unchanged in both groups over the course of the study.

While there were five deaths, 8 nonfatal strokes and 8 nonfatal heart attacks over the 8-month median follow-up period in the untreated group, none of these events occurred among those who received testosterone.

Long-term testosterone therapy, in men with testosterone deficiency, was well tolerated with excellent adherence suggesting a high level of patient satisfaction, authors Karim Sultan Haider and colleagues conclude. A progressive and sustained improvement in urinary and sexual function was recorded in men receiving long-term testosterone therapy, contributing to overall improvement in quality of life.

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Testosterone replacement therapy associated with improved urinary, sexual function – ProHealth

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Testosterone Replacement Therapy Market Global Insights and … – E News Access (press release)

Global Testosterone Replacement Therapy Market Research Report 2017 to 2022 provides a unique tool for evaluating the market, highlighting opportunities, and supporting strategic and tactical decision-making. This report recognizes that in this rapidly-evolving and competitive environment, up-to-date marketing information is essential to monitor performance and make critical decisions for growth and profitability. It provides information on trends and developments, and focuses on markets and materials, capacities and technologies, and on the changing structure of the Testosterone Replacement Therapy Market.

Companies Mentioned are AbbVie, Pfizer, Eli Lilly, Teva Pharmaceuticals, Mylan, Bayer HealthCare Pharmaceuticals, Antares Pharma, Ferring Pharmaceuticals, Allergan, Antares Pharma, Sandoz, Clarus Therapeutics, Juniper Pharmaceuticals, Endo International, Acerus Pharmaceuticals, Forendo Pharma, MetP Pharma, Repros Therapeutics

The Global Testosterone Replacement Therapy market consists of different international, regional, and local vendors. The market competition is foreseen to grow higher with the rise in technological innovation and M&A activities in the future. Moreover, many local and regional vendors are offering specific application products for varied end-users. The new vendor entrants in the market are finding it hard to compete with the international vendors based on quality, reliability, and innovations in technology.

This report segments the Global Testosterone Replacement Therapy market on the basis of types, Gels, Injectables, Patches, Other On the basis of application, the Global Testosterone Replacement Therapy market is segmented into Hospitals, Clinics, Other

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This independent 112 page report guarantees you will remain better informed than your competition. With over 165 tables and figures examining the Testosterone Replacement Therapy market, the report gives you a visual, one-stop breakdown of the leading products, submarkets and market leaders market revenue forecasts as well as analysis to 2022.

Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), and market share and growth rate of Testosterone Replacement Therapy in these regions, from 2012 to 2022 (forecast), covering Global, Europe, Japan, China, India , Southeast Asia, Other.

The report provides a basic overview of the Testosterone Replacement Therapy industry including definitions, classifications, applications and industry chain structure. And development policies and plans are discussed as well as manufacturing processes and cost structures.

Then, the report focuses on Global major leading industry players with information such as company profiles, product picture and specifications, sales, market share and contact information. Whats more, the Testosterone Replacement Therapy industry development trends and marketing channels are analyzed.

The research includes historic data from 2012 to 2016 and forecasts until 2022 which makes the reports an invaluable resource for industry executives, marketing, sales and product managers, consultants, analysts, and other people looking for key industry data in readily accessible documents with clearly presented tables and graphs. The report will make detailed analysis mainly on above questions and in-depth research on the development environment, market size, development trend, operation situation and future development trend of Testosterone Replacement Therapy on the basis of stating current situation of the industry in 2017 so as to make comprehensive organization and judgment on the competition situation and development trend of Testosterone Replacement Therapy Market and assist manufacturers and investment organization to better grasp the development course of Testosterone Replacement Therapy Market.

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The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors.

There are 15 Chapters to deeply display the Global Testosterone Replacement Therapy market.

Chapter 1, to describe Testosterone Replacement Therapy Introduction, product scope, market overview, market opportunities, market risk, market driving force;

Chapter 2, to analyze the top manufacturers of Testosterone Replacement Therapy, with sales, revenue, and price of Testosterone Replacement Therapy, in 2016 and 2017;

Chapter 3, to display the competitive situation among the top manufacturers, with sales, revenue and market share in 2016and 2017;

Chapter 4, to show the Global market by regions, with sales, revenue and market share of Testosterone Replacement Therapy, for each region, from 2012to 2017;

Chapter 5, 6, 7, 8 and 9, to analyze the key regions, with sales, revenue and market share by key countries in these regions;

Chapter 10 and 11, to show the market by type and application, with sales market share and growth rate by type, application, from 2012 to 2017;

Chapter 12, Testosterone Replacement Therapy market forecast, by regions, type and application, with sales and revenue, from 2017to 2022;

Chapter 13, 14 and 15, to describe Testosterone Replacement Therapy sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source.

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Testosterone Replacement Therapy Market Global Insights and … – E News Access (press release)

Recommendation and review posted by Alexandra Lee Anderson

What You Need to Know About Testosterone Replacement – Westchester Magazine

It’s an increasing trend among men.

By Paul Adler

Published: 2017.08.23 02:01


As men age, their testosterone levels naturally dip potentially ushering in a host of negative effects including decreased sex drive and muscle mass. Testosterone therapy has risen over the last few decades to fill the gap, but many men wonder when it is time to worry and what the drawbacks of such treatments could be. We asked Michael Werner, MD, the medical director at the Purchase-based Maze Mens Sexual and Reproductive Health when testosterone replacement is truly necessary and what it really entails.

According to Werner, there are a host of symptoms to watch out for when you are worried you may have low levels of the hormone. Men should seek medical help when they [exhibit] some of the symptoms of low testosterone, he says. These include decreased interest in sex, worsening erections, decreased energy, lack of mental focus or fogginess, and difficulty taking off fat and putting on muscle However, Werner insists that the decision of whether or not a man needs testosterone replacement should be made with his doctor.

Werner adds that once the diagnosis that an individuals testosterone levels are low has been made, the patient is then in a place to decide with his doctor which treatment is best for him and his lifestyle. Before seeking treatment, It is also important to note that every patient on testosterone replacement therapy needs to do so under a doctors care and get regular checkups to watch for elevated hematocrit (red blood cell) levels and to make sure his body is not making too much estrogen, explains Werner.

So, what happens once a patient starts receiving the treatment? The first signs the testosterone is doing its job may be increased energy and improved mental acuity, says Werner. In a few months, body fat tends to diminish and men will notice improved exercise performance. According to Werner, it can take six months for men to notice an improvement in erectile function, and nine months for an improvement in libido. He also notes that, for many men, cholesterol levels will improve and overall heart health can get better.

However, the therapy has been linked to serious maladies in the past. The two major concerns that physicians have had were that testosterone replacement therapy could increase the incidence of prostate cancer, or cardiovascular disease, he explains. The vast preponderance of medical evidence does not support these concerns, at all, and the views in the medical community are slowly changing.

As for negative effects, Werner says that some men might notice temporary acne, although most notice no negative effects of being on the treatment. Testosterone replacement therapy can be as inexpensive as $60 for a 3-month vial for self-injection, or hundreds of dollars for implanting pellets which last three months, says Werner. Most insurance companies cover testosterone replacement therapy medication and treatment, when it is medically indicated.

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What You Need to Know About Testosterone Replacement – Westchester Magazine

Recommendation and review posted by Alexandra Lee Anderson

Wider use of testosterone therapy is not risk free – The Pharmaceutical Journal

As one of those whose passions were aroused by testosterone replacement therapy (TRT) in men, I am delighted that Clinical Pharmacist has provided Geoff Hackett with a platform to clarify the current clinical position (Clinical Pharmacist 2017;9:195). Hackett rightly points out that we should have no truck with those who have preconceived views on testosterone and interpret studies based on these preconceptions.

Indeed, with the feel of his erudite hand firmly on my collar, I confess that my own comments on this matter which used the inflammatory term male menopause (The Pharmaceutical Journal 2017;298;100) did not have the benefit of more recent studies quoted in this excellent article and I apologise if I appeared trite, cynical or indifferent. It is good to have a dispassionate, objective review of this subject focused on the facts.

My initial concerns about safety and efficacy of TRT were based on a letter from my colleague Sid Dajani (The Pharmaceutical Journal 2016;297:364) who appeared to me to be promoting the medicalisation of the ageing male population a population I am now part of and hope to be for some time by screening for low testosterone levels and, where identified, treating. In fact, I believe they should first stop smoking, reduce their drinking, take more exercise and relax. These steps would reduce their risk of cardiovascular disease and diabetes yet, I admit, they may not enjoy an early morning erection. Dajani was defiant about my concerns (The Pharmaceutical Journal 2017;298:235) over efficacy and I now know that I was wrong. There is good evidence for efficacy across a number of clear clinical outcomes. Hackett has convinced me of this.

But what about safety? Hackett attempts to convince me (and it may be just my stupidity so forgive me) but he seems to find studies that disagree with his case methodologically flawed whereas supportive studies do not attract such censure. I know that by saying that I risk being called out as one of the biased evangelical healthcare professionals dispensing their own standards of social justice. I hope not.

For example, he severely criticises the methodology in a paper published by Vigen et al[1]. The conclusion of this paper states: Long-term exposure to testosterone replacement therapy was associated with reduced risks of mortality, cardiovascular events, and prostate cancer. However, testosterone replacement therapy increased the risk of mortality and cardiovascular events with short durations of therapy. In view of the limitations of observational data and the potential for selection bias, these results warrant confirmation in a randomised trial.

I seem to understand what these authors are saying as; if the treatment does not kill you in the first few months then it might save your life. Very Nietzsche indeed.

I bow to Hacketts expertise on methodology. However, he also quotes a paper by Wallis et al[2] and without any criticisms of its methodology, quotes this study as supporting a decreased risk in all-cause mortality from TRT making no reference to the authors safety concerns: Use of testosterone therapy in this cohort of veterans with significant medical comorbidities was associated with increased risk of mortality, myocardial infarction, or ischaemic stroke. These findings were not modified by the presence of coronary artery disease. Future studies including randomised controlled trials are needed to properly characterise the potential risks of testosterone therapy in men with comorbidities.

This is clearly a complex clinical area. I would respectfully suggest that, accepting that TRT has an important clinical role when in the hands of experts such as Hackett, wider use of TRT is not a risk free-panacea for the ills of the ageing baby boomers.

Terry Maguire


Citation: Clinical Pharmacist, CP August 2017 online, online | DOI: 10.1211/CP.2017.20203367

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Wider use of testosterone therapy is not risk free – The Pharmaceutical Journal

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Dr. Roach: Testosterone replacement can affect sex drive, osteoporosis –

Dear Dr. Roach: I am a 67-year-old male in fair to good health (more good than fair, really). In a recent column, you mentioned that a good testosterone level for a man taking a replacement would be between 500-600 ng/dl.

In November, I was tested for my testosterone level. At the time, I was (and still am) suffering from a low sex drive and erectile dysfunction. My level was 290 ng/dl. The reference range my primary care doctor bases his judgment on has an acceptable range from 193-950 ng/dl; hence he said my level was low normal.

When looking at the symptoms of low testosterone, I noted that I have at least four symptoms: low sex drive, ED (for which I have already been treated with a prosthetic implant), loss of body hair (especially my legs) and, most notably, osteoporosis (for which I take alendronate sodium, 70 mg weekly). I was diagnosed in November.

I also am being treated for depression and anxiety disorder, and have been since 2001. I dont know if this is related to my testosterone level.

Should I talk to my doctor about the disparity Ive found in reference ranges? Should I be seeking treatment for the low testosterone? J.P.P.

Answer: I think you definitely should speak to your primary care physician. You also might benefit from a discussion with a urologist or endocrinologist with experience in treating men with testosterone replacement.

When we look at normal testosterone levels by age, we find that older men have lower normal levels; however, given your symptoms and result, I certainly would think a trial of testosterone would be appropriate. I must say that I am surprised that you had an implant placed without a trial of testosterone first. I also am surprised you were treated for osteoporosis without a trial of testosterone replacement, which has been shown to improve bone density in men with low testosterone levels (one study treated men with a testosterone level below 350; another if they were below 320). Low libido and erectile dysfunction both frequently respond to testosterone replacement: Some men get benefit in their mood as well. You sound to me like an excellent candidate for testosterone replacement.

Dr. Roach writes: A recent column from a man asking for alternatives to coronary bypass surgery generated many letters with the same question: Why not advise a change in diet as an alternative to surgery?

There are two reasons. The first is that its not an alternative to surgery: Its a medical recommendation that should be made for every person with diagnosed coronary disease. Nearly all people can improve their diet. While a vegan diet was the most common recommendation I received, it still is not clear that a vegan diet is most likely to reduce coronary disease. In the vast literature on diet, there are only a few well-done studies that show a benefit. The clearest benefit has been from the Mediterranean diet, but a very-low-fat, plant-based diet, in combination with stress reduction and smoking cessation, has been shown to help reverse coronary lesions.

The second reason is that if someone needs the arteries in his or her heart reopened, the changes in diet are not likely to reverse blockages in the time needed to prevent a heart attack.

Healthy diet changes are appropriate for all people with heart blockages, but inadequate by themselves in the short term, in people with symptoms of angina and serious blockages.


Dr. Keith Roach is a syndicated columnist with North America Syndicate Inc., P.O. Box 536475, Orlando, FL 32853-6475.

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Dr. Roach: Testosterone replacement can affect sex drive, osteoporosis –

Recommendation and review posted by Alexandra Lee Anderson