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Auxilium Pharmaceuticals Inc Announces Positive Top-Line Data From XIAFLEX Frozen Shoulder Syndrome Phase IIa Study

Monday, 25 Mar 2013 07:00am EDT 

Auxilium Pharmaceuticals Inc announced positive data for collagenase clostridium histolyticum or CCH which is being developed for the potential treatment, if approved by the U.S. Food and Drug Administration (FDA), of adult patients with adhesive capsulitis (AC), commonly known as Frozen Shoulder syndrome (FSS). FSS is a common, prolonged, painful condition of the shoulder in which increased capsular collagen thickening and subsequent capsular contraction in the shoulder joint is thought to cause a loss of range of motion in the shoulder. The condition is believed to affect approximately two to 5% of the general adult population and the full duration of the disease can last from approximately 1 year to up to 3.5 years.1 The majority of cases are curr ently managed conservatively with prolonged physical therapy and occasionally with steroid injections. It is estimated that approximately 300,000 cases of FSS are diagnosed annually and approximately 10% are treated with an invasive intervention (surgery or manipulation under anesthesia) on an annual basis. The phase IIa study was an open-label, controlled dose-ranging study designed to assess the safety and efficacy of CCH for the treatment of Stage 2 unilateral idiopathic FSS in comparison to an exercise-only control group. 

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