Phase II study of Xiaflex (Auxilium Pharma) shows benefits for patients with Adhesive Capsulitis
Auxilium Pharmaceuticals has announced positive data for Xiaflex (clostridial collagenase injection), from Auxilium Pharma, for the treatment of adults with Adhesive Capsulitis (AC), or Frozen Shoulder Syndrome. The Phase IIa study was an open-label, controlled dose-ranging study designed to assess the safety and efficacy of Xiaflex for the treatment of Stage 2 unilateral idiopathic AC in comparison to an exercise-only control group. The study involved 50 adult men and women at 11 sites throughout the US.
Both the 0.58mg(1mL) and 0.58mg(2mL) dosing arms showed positive, statistically significant improvement from baseline in forward flexion vs. the exercise-only group. The 0.58mg(1mL) dosing arm also showed statistically significant improvement from baseline in shoulder abduction vs. the exercise-only group. Positive trends with improvement in degrees were also seen in other active range of motion assessments vs. the exercise-only group. The initiation of next phase trials is expected in the second half of 2013.
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