) 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
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.
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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.
WuXi Pharma Tech (Cayman) Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).