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Auxilium Pharmaceuticals, Inc. Completes Enrollment of XIAFLEX® Phase III Double-Blind Studies for Peyronie's Disease

Wed, 03/09/2011 - 3:35am
Bio-Medicine.Org

MALVERN, Pa., March 9, 2011 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company, today announced it has reached the target enrollment for the double-blind placebo-controlled phase III program of XIAFLEX® for the treatment of Peyronie's disease.  In accordance with the study design, all enrolled patients will have received their first injection of either XIAFLEX or placebo by the end of March 2011.  The Company will exceed its enrollment target of 600 patients.  Peyronie's disease is the development of a collagen plaque on the penis that can cause the penis to curve during erection, often interfering with or preventing intercourse and resulting in psychological distress or bother for the patient.

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"We are very pleased to achieve this important development milestone in Peyronie's disease and advance what can potentially be a second indication for XIAFLEX," said Armando Anido, Chief Executive Officer and President of Auxilium. "We believe completing the enrollment of over 600 patients at sites in the U.S. and Australia in less than six months speaks to the enthusiasm in the urology community and their prospective patients for a non-surgical treatment alternative. We anticipate reporting top-line results in the first half of 2012."  

The late stage global development plan for XIAFLEX for Peyronie's disease consists of four clinical studies and is known by the acronym IMPRESS – The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies.  The two randomized, double-blind, placebo-controlled phase III studies enrolled a total of over 600 patients at approximately 70 sites in the U.S. and Australia, with a 2:1 ratio of XIAFLEX to placebo.  T

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