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Testosterone Undecanoate Achieves and Maintains Normal Testosterone Levels in Hypogonadal Men With Five Injections Per Year, New Data Show
Date:4/28/2009

Long-term Data Presented at AUA Annual Meeting

CHICAGO, April 28 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today released new long-term clinical trial data in men with hypogonadism who were treated for 21 months with testosterone undecanoate (NEBIDO(R) -- 750 mg) injection, a long-acting testosterone replacement therapy in development in the U.S. for treatment of hypogonadism. Results showed that average testosterone levels were maintained within the normal range over the 21-month study, and NEBIDO was generally well tolerated. The long-term clinical trial data were presented at the annual meeting of the American Urological Association.

Previously reported Phase III data evaluated NEBIDO's effectiveness and safety over the initial six-month treatment period in these hypogonadal men, with 94 percent of patients achieving an average testosterone level within the normal range (300-1000 ng/dL) over the 10-week treatment interval. At initiation of treatment, the average testosterone level for the patients rose into the normal range at the first sampling point, four days following the first injection. The new long-term data showed that average testosterone levels remained in the normal range throughout the 21-month study, and that NEBIDO was generally well tolerated. NEBIDO is currently under review at the U.S. Food and Drug Administration.

"Symptoms of low testosterone can be non-specific and may be dismissed as the natural consequence of aging," said Dr. Abraham Morgentaler, a leading investigator of the study and Director of Men's Health Boston, and Associate Clinical Professor of Urology at Harvard Medical School. "But treating hypogonadism can result in significant health benefits for patients."

STUDY RESULTS

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