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Auxilium Pharmaceuticals, Inc. Announces First Patient Dosed in XIAFLEX® Study for Frozen Shoulder Syndrome
Date:12/1/2011

n benefit in treating adult Dupuytren's contracture in patients with a palpable cord."

The phase IIa study is an open-label, controlled dose-ranging study designed to assess the safety and efficacy of XIAFLEX for the treatment of Frozen Shoulder syndrome in comparison to an exercise-only control group. The study will involve approximately 50 adult men and women at approximately nine sites throughout the U.S. Topline study results are expected in the first half of 2013.

To qualify for the Frozen Shoulder syndrome study, patients must have unilateral idiopathic adhesive capsulitis of the shoulder with restricted range of motion in the affected shoulder for at least three months, but not more than 12 months. Following screening and determination of study eligibility, subjects will be assigned to four groups that vary in dosing (injection volume and concentration) or a fifth group receiving shoulder exercises only. Patients may receive up to three ultrasound-guided injections of varying doses of XIAFLEX (ranging from 0.29 mg to 0.58 mg in varying concentrations) separated by a minimum of 21 days and all patients will be instructed to perform home shoulder exercises. The study's primary endpoint is the change (degrees) from baseline to the day 92 follow-up in forward flexion (active) in the affected shoulder. Safety assessments, including immunogenicity testing, will be made during all study visits. More information on the study, including study sites participating in this trial, can be found at clinicaltrials.gov.

About Frozen Shoulder Syndrome
Frozen Shoulder syndrome, also known as idiopathic adhesive capsulitis, is a common, prolonged, and painful disorder of diminished shoulder motion.(1)  The full duration of the frozen stage of disease can last from 1 to 3.5 years with a mean of 30 months.(4)  Increased capsular collagen thickening and subsequent capsular contraction in the glenohumeral joint is thought to cause restrictio
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SOURCE Auxilium Pharmaceuticals, Inc.
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