Endo's FORTESTA Gel for treatment of 'Low T' in males is now available in pharmacies

Mar 3 2011

Endo Pharmaceuticals (Nasdaq: ENDP) announced that FORTESTA™ Gel – recently approved by the U.S. Food and Drug Administration for the treatment of low testosterone, or 'Low T' in adult males – is now available by prescription in pharmacies across the country. The clear, colorless and odorless gel comes in a small (60 g) canister with a pump that delivers 10 mg of testosterone with each actuation (pump). FORTESTA Gel is applied once-a-day with one finger directly to the front and inner thighs – not to the upper body.

The introduction of FORTESTA Gel in the U.S. comes at a time when only about 1.3 million (9 percent) of the estimated 14 million men with Low T are actually receiving treatment.

"We are excited to bring FORTESTA Gel to market in the United States and are confident that once men try it, FORTESTA Gel will quickly become a significant treatment option for many men with Low T," said Julie McHugh, Chief Operating Officer, Endo Pharmaceuticals. "Endo is committed to providing additional treatment options for the millions of men with Low T who are currently not being adequately treated for the condition."

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 testosterone blood level within the normal range at day 90. The most common side effect in this trial was application site reactions.

SOURCE Endo Pharmaceuticals