Fortesta is Approved by the FDA to Treat Low Testosterone (Low T, Hypogonadism)

The United States Food and Drug Administration (FDA) this week approved Fortesta – a topical gel that provides testosterone replacement therapy for men. One of the symptoms of low testosterone (also referred to as “Low T” or hypogonadism) is erectile dysfunction. Other symptoms include:  fatigue, decreased sexual desire, loss of energy, regression of secondary sexual characteristics, mood depression and osteoporosis.

Men who have erectile dysfunction (ED) should speak with their local doctors in order to find out what is causing the condition.

If men have low testosterone, their testes are not producing normal amounts of this male sex hormone. While it is estimated that as many as half of all American men over age 50 suffer from erectile dysfunction, it is also believed that low testosterone affects almost 14 million men in the U.S. A low percentage of men actually seek help for these treatable conditions, however. Estimates say, for example, that less than 10 percent of men seek treatment for Low T.

If you are suffering from erectile dysfunction, or any of the Low T symptoms mentioned above, there is no reason not to seek help and improve your sexual well being – and perhaps your overall health.

Fortesta, already approved in Europe under the names Tostran, Tostrex and Itnogen, is a clear, colorless and odorless gel. It should be applied gently with one finger to the front and inner thighs – not the upper body. The medication is provided in a metered-dose pump that ensures a correct dosage for each application.

Endo Pharmaceuticals Holdings Inc. developed Fortesta, and plans to have the drug on the market by early 2011. Fortesta showed very promising results in its 90-day, Phase III clinical trial, in which 78 percent of the sample (all male patients with Low T) returned their testosterone levels to within a normal range within 90 days of beginning treatment. Low T can begin to affect men as early as age 40.

The most common side effects associated with Fortesta were application-area reactions (skin redness or irritation) increased prostate specific antigen (PSA), and abnormal dreams. Overall, Fortesta exhibited an impressive safety profile, but it may provide additional side effects, and it must be applied and used as prescribed. Men who use Fortesta must be careful not to allow women or children to touch application areas.

Pennsylvania-based Endo Pharmaceuticals reached an agreement with a UK-based drug company called ProStrakan Group to market Fortesta. The deal may could be worth up to $210 million if the topical gel meets sales goals. The price of Endo’s shares have risen 72 percent this year, according to Bloomberg.

Fortesta should not be used if a man has or might have prostate cancer, or breast cancer. Men who may want to try Fortesta should tell their local doctor about all medications they are taking, especially insulin, medicines that decrease blood clotting, and corticosteroids. As mentioned earlier, erectile dysfunction and Low T are very treatable, and men who have these conditions now have proven medications that can help. Talk to your doctor to find out more.

For additional information about Fortesta, view the complete prescribing information document, including the Medication Guide.

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