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Auxilium Pharmaceuticals, Inc. Announces Initiation of XIAFLEX® Phase III Studies for Peyronie's Disease
Date:10/11/2010

ients.  XIAFLEX will be administered two times a week every six weeks for up to four treatment cycles (2 x 4).  Each treatment cycle will be followed by a penile modeling procedure.  Patients will be followed for 52 weeks post-first injection in the double-blind studies and for 36 weeks in the open label trial.  

The trials' co-primary endpoints are the change from baseline in the Peyronie's disease bother domain of the Peyronie's Disease Questionnaire (PDQ) compared to placebo and percent improvement from baseline in penile curvature compared to placebo.  The PDQ will have at least three domains, which will include Peyronie's disease bother, severity of psychological and physical symptoms of Peyronie's disease, and penile pain.  Safety measurements will include adverse event monitoring, immunogenicity testing and clinical labs.

"We are encouraged by the clinical profile of XIAFLEX, which emerged from our earlier phase IIb clinical trial in Peyronie's disease.  XIAFLEX was well-tolerated and produced clinically significant reductions in both penile curvature and disease bother," said Dr. Jim Tursi, Auxilium's Vice President of Clinical Research & Development.  "Over the last six months, our team, in conjunction with the U.S. Food and Drug Administration (FDA), outside experts and men with Peyronie's disease, has spent a considerable amount of time and effort to refine the PDQ, which has now been accepted for use in the phase III clinical trials by the FDA's Study Endpoint and Label Development (SEALD) Division."

Conference Call and WebcastAuxilium will hold a webcast and conference call today, October 11, 2010 at 8:30 a.m. ET, to:

  • discuss the initiation of the global phase III program of XIAFLEX for the treatment of Peyronie's disease; and
  • update the leading indicators for the launch of XIAFLEX in Dupuytren's contracture.

  • The presentation slides to be used during the cal
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    SOURCE Auxilium Pharmaceuticals, Inc.
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