Endo gets green light for new testosterone gel

The FDA is giving a green light to a new testosterone gel developed by Endo Pharmaceuticals ($ENDP) and ProStrakan. Shares of Endo were buoyed by the news, Reuters notes.

Fortesta was studied as a treatment for hypogonadism, or low testosterone in men. Once it hits the market, the treatment will be applied along the inner thighs of patients to help avoid any accidental smearing on children or women, who could suffer some unpleasant side effects.

The approval for Fortesta follows close on the heels of another approval for Axiron, a testosterone therapy developed by Eli Lilly and Acrux.  AndroGel and Testim, which is expected to earn $633 million this year, are already on the market. Those two therapies contain 1 percent of the active ingredient, according to Reuters, while Fortesta will have a 2 percent concentration.

"Declining blood levels of testosterone can occur in men beginning as early as age 40. The symptoms of low testosterone can be non-specific and often associated with other chronic medical problems," said Adrian Dobs, M.D., M.H.S., professor of medicine and oncology, Johns Hopkins University School of Medicine. "Fortesta Gel is an important new treatment option for men who are diagnosed with low testosterone."

Regulators have been keenly sensitive to the potential safety issues involved. If it comes in contact with children, the treatments could trigger premature physical development, including enlarged sexual organs.

- here's the Endo press release
- read the Reuters report