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Auxilium Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 2b Frozen Shoulder Syndrome Study of Collagenase Clostridium Histolyticum
Date:12/13/2013

he triple helix collagen structure. XIAFLEX has been granted Orphan Drug Designation in the U.S. by the FDA for DC and PD.

 "The initiation of our Phase 2b Frozen Shoulder syndrome study represents another development milestone for Auxilium as we further evolve our pipeline and advance a fourth potential indication for CCH," explained Adrian Adams, Chief Executive Officer and President of Auxilium. "We believe that our continued measured investments in research and development, together with the upcoming product launches of XIAFLEX in Peyronie's disease and STENDRA™ in erectile dysfunction, position the Company well for growth and shareholder value creation."

The Phase 2b study is a double-blind, placebo-controlled study of the safety and efficacy of CCH for the treatment of Stage 2 (frozen stage) unilateral idiopathic FSS. The study will enroll approximately 300 adult men and women at approximately 35 sites in the U.S. and Australia. Subjects will be randomized 3:1 to receive CCH or placebo and will receive up to three ultrasound-guided injections of study drug. Each injection will be separated by a minimum of 21 days. All subjects will also perform home shoulder exercises after the first injection.

In a prior Auxilium Phase 2a FSS study, both the 0.58mg (1mL) and 0.58mg (2mL) dosing arms showed statistically significant improvement (p<0.05)  from baseline in forward flexion versus the exercise-only group. The 0.58mg (1mL) dosing arm also showed statistically significant improvement (p<0.05) from baseline in shoulder abduction versus the exercise-only group. For this Phase 2b study, the dose selected will be 0.58 mg (1mL). 

The Phase 2b study's primary endpoint is the change (degrees) from baseline to the Day 95 follow-up visit in active forward flexion in the affected shoulder compared to placebo. Patients will also be assessed using the Ameri
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SOURCE Auxilium Pharmaceuticals, Inc.
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