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Auxilium Pharma Reports Positive Top-line Data From XIAFLEX Phase IIIb Trial

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7/30/2012 7:10 AM ET

Auxilium Pharmaceuticals Inc. (AUXL: Quote) reported positive top-line data from its open-label phase IIIb study, assessing XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. The company enrolled 60 patients at 8 sites throughout the U.S. and Australia. During the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the company to seek Food and Drug Administration approval and expansion of the Dupuytren's label.

Based on research by SDI Health, LLC estimating that 35% - 40% of annual Dupuytren's surgeries in the U.S. are performed to treat two or more cords concurrently, Auxilium is conducting these trials to seek a multicord indication for XIAFLEX from the FDA.

In this phase IIIb multicord trial, 60 patients received two concurrent injections of 0.58 mg of XIAFLEX per affected hand and efficacy was based on a single injection per contracted joint.

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by RTT Staff Writer

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