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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

can Shoulder and Elbow Surgeons (ASES) Scale for function and pain as well as additional patient reported outcome measures.  Safety assessments will be made during all study visits and immunogenicity testing will be performed at screening and at the end of the study.

"We are very excited to be moving into this next phase of development for CCH in the potential treatment of Frozen Shoulder," said Dr. James Tursi, Chief Medical Officer of Auxilium. "FSS is a condition with no approved therapies and limited treatment options. Innovative treatment approaches such as CCH, if approved by the FDA, may allow patients quicker relief from limits in range of motion and associated pain."

About Frozen Shoulder SyndromeFSS, also known as adhesive capsulitis, can be a prolonged, and painful disorder of diminished shoulder motion. The full duration of the frozen stage (Stage 2) of disease can last from 1 to 3.5 years with a mean of 30 months. Increased capsular collagen thickening and subsequent capsular contraction in the glenohumeral joint is thought to cause restriction in both active and passive range of motion in the shoulder.[iii] As the condition progresses, pain can become more severe and is accompanied by stiffness and decreased range of motion. The stiffening may increase to the point where the natural arm swing that accompanies normal gait is lost.[iv] The most common treatments for FSS are long-term intensive physical therapy, corticosteroids, manipulation under anesthesia and/or arthroscopic release and each treatment has differing associated risks. Drugs are often used to manage associated pain, but none have been demonstrated to have an impact on the course of FSS. 

FSS is estimated to affect approximately two to five percent of the general adult populationi and has an increased incidence among patients with diabetes,[v] Dupuytren's contracture, and thyroid disea
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SOURCE Auxilium Pharmaceuticals, Inc.
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