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BioSpecifics Technologies recently announced positive top line data from a phase IIa study on Xiaflex for the potential treatment of frozen shoulder syndrome (FSS) in adults. BioSpecifics has a strategic partnership with Auxilium Pharmaceuticals, Inc. for Xiaflex.

The open-label controlled dose-ranging phase IIa study, conducted by Auxilium Pharma, evaluated the safety and efficacy of Xiaflex for the treatment of stage II unilateral idiopathic frozen shoulder in comparison with an exercise-only group.

The study involved 50 adults, equally divided into 5 groups. Four such cohorts received up to three injections of Xiaflex (doses ranging from 0.29 mg to 0.58mg in three different volumes: 0.5, 1.0, or 2.0 mL) in addition to home shoulder exercises. The fifth cohort only performed home shoulder exercises.

Dosing arms – 0.58mg (1mL) and 0.58mg (2mL) – showed statistically significant positive improvement from baseline in forward flexion versus the exercise-only group.
 
We note that Xiaflex, an injectable enzyme, is already available for the treatment of Dupuytren’s contracture (DC). DC refers to a condition that affects the connective tissue in the palm known as palmar fascia. BioSpecifics Technologies /Auxillium Pharma are evaluating the drug for other indications also. Xiaflex is currently under FDA review for the Peyronie’s indication (PD). A response from the agency should be out by Sep 6, 2013.

Both BioSpecifics and Auxilium Pharma carry a Zacks Rank #3 (Hold). Currently, companies like Lannett Company, Inc. (LCI ) and WuXi Pharma Tech (Cayman) Inc. look more attractive with a Zacks Rank #1 (Strong Buy).

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