Media, Inc.

All Penny News: Trimel Seeking FDA Approval of Refined Protocol of CompleoTRT for Low Testosterone


Mississauga, ON -- (SBWIRE) -- 12/20/2013 -- Media, Inc. ( announces its latest article titled “Trimel Seeking FDA Approval of Refined Protocol of CompleoTRT for Low Testosterone.”

Companies mentioned in this article include Abbott Laboratories (NYSE:ABT), Eli Lilly (NYSE:LLY) and Trimel Pharmaceuticals (TSX:TRL).

Article Excerpt:

To most people, getting old, well…sucks. There are some great things that can only come from age, experience, successes, children, grandchildren, etc., but the wear-down of the body is something that is generally not very enjoyable and fought tooth-and-nail by most. The good thing is that virtually no matter what it is – stiff joints, brittle bones, gray hair, disease – our advertising-rich society let’s us know that there’s a treatment for it. In recent years, a person can barely turn on a television without seeing an ad for hypogonadism, a condition better known by the more-ad-friendly nickname of “Low T,” or low testosterone.

Thanks to the massive marketing efforts of biotech behemoths like Abbott Laboratories (NYSE:ABT) with its Androgel product and Eli Lilly (NYSE:LLY) for its drug Axiron, Low T is now a widely publicized condition that is easily treated. These efforts helped drive the U.S. Low T market upward by 30 percent in 2012 to more than $2.1 billion.

Testosterone drugs are not without risk, though. In addition to potential personal side effects, such as low sperm count or chances of hastening prostate cancer, they carry a different type of concern than most drugs as they can affect people around the user. 90 percent of the Low T market is represented by gel formulations where the testosterone is absorbed through the skin, making it possible for other people, for which the drug is not intended, to come in contact with it, which can lead to unwanted side effects. Women and children are especially likely to be affected, with symptoms for women including new hair growth or acne, and kids possibly experiencing signs of early maturation. Pregnant women are at risk of harming the unborn baby.

As such, all of the current testosterone gels have a “black box” warning related to transference to third parties.

Trimel Pharmaceuticals (TSX:TRL) has completed Phase III clinical trials and submitted a New Drug Application to the U.S. Food and Drug Administration requesting marketing approval for its CompleoTRT, a bioadhesive intranasal gel formulation of testosterone. As we wrote in an article in April 2012, the new drug has strong potential because it is applied to the interior lateral wall of the nasal cavity and absorbed completely in 15 to 30 minutes, essentially eliminating the risk of transference to third parties. If approved, Trimel’s drug could avoid a “black box” warning, which may make it more appealing to clinicians and support stronger sales.

The full version of this article can be found at:

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