FDA approves Endo's FORTESTA Gel for low testosterone

Endo PharmaceuticalsDec 29 2010

Endo Pharmaceuticals (Nasdaq: ENDP) today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.  Low T is a condition that has an estimated prevalence in nearly 14 million men in the United States, yet only about 1.3 million, (9 percent) are currently being treated. Endo Pharmaceuticals expects to introduce FORTESTA™ Gel in the United States in early 2011.

"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, Division of Endocrinology and Metabolism in Baltimore, Md., and principal investigator of the FORTESTA Gel Phase III clinical trial. "FORTESTA Gel is an important new treatment option for men who are diagnosed with low testosterone."

FORTESTA Gel is a clear, colorless, odorless gel that is gently applied with one finger to the front and inner thighs, and not the upper body.  FORTESTA Gel comes in a metered-dose pump that delivers the correct dose per complete depression.  Patients using FORTESTA Gel should apply the product as directed.  Safety and efficacy of FORTESTA Gel in males less than 18 years old have not been established.  

"The approval of FORTESTA™ Gel reinforces our commitment to men's health by providing an important new treatment option for millions of men with Low T," said David Holveck, chief executive officer, Endo Pharmaceuticals.

In a 90-day, multicenter, open-label, non-comparative, pivotal Phase III trial involving men with hypogonadism, 78 percent of patients using FORTESTA™ Gel had an average serum total testosterone concentration within the normal range at day 90. The most common side effect in this trial was application site reactions.