FDA Approves Fortesta Gel For Treatment Of Low Testosterone

Endo Pharmaceuticals (Nasdaq: ENDP) announced, yesterday, 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.

Important Safety Information for FORTESTA gel

FORTESTA Gel can transfer from your body to others. This can happen if other people come into contact with the area where the FORTESTA Gel was applied. Signs of puberty that are not expected (for example, pubic hair) have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products like FORTESTA Gel.

Women and children should avoid contact with the unwashed or unclothed areas where FORTESTA Gel has been applied. If a woman or child makes contact with the FORTESTA Gel application area, that area on the woman or child should be washed well with soap and water right away.

To lower the risk of transfer of FORTESTA Gel from your body to others, you should: Apply FORTESTA Gel only to the front and inside area of your thighs that will be covered by clothing and wash your hands right away with soap and water after applying FORTESTA Gel. After the gel has dried, cover the application area with clothing and keep the area covered until you have washed the application area well or have showered. If you expect another person to have skin-to-skin contact with your thighs, first wash the application area well with soap and water.

Stop using FORTESTA Gel and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to FORTESTA Gel.

Do not use FORTESTA Gel if you have breast cancer, have or might have prostate cancer, are pregnant, may become pregnant, or are breastfeeding.

FORTESTA Gel may harm your unborn or breastfeeding baby. Women who are, or who may become pregnant should avoid contact with the area of skin where FORTESTA Gel has been applied.

Other possible serious side effects include: if you already have enlargement of your prostate gland your signs and symptoms can get worse while using FORTESTA Gel; possible increased risk of prostate cancer; in large doses FORTESTA Gel may lower your sperm count; swelling of your ankles, feet, or body, with or without heart failure; enlarged or painful breasts; have problems breathing while you sleep (sleep apnea); increased red blood cell count; blood clots in the legs (his can include pain, swelling or redness of your legs). Call your healthcare provider right away if you have any of the serious side effects listed above.

Tell your HCP about all of your medications, especially insulin, medicines that decrease blood clotting, and corticosteroids.

The most common side effects of FORTESTA Gel include skin redness or irritation where FORTESTA Gel is applied, increased prostate specific antigen (PSA), and abnormal dreams.

Full prescribing information, including the Medication Guide, is available at http://www.endo.com/FORTESTA.aspx.

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