Auxilium Pharmaceuticals, Inc.
) recently dosed its first patient for the phase II study on
Xiaflex for the treatment of frozen shoulder syndrome (FSS or
We note Xiaflex, in-licensed from
BioSpecifics Technologies Corp.
), is approved in the U.S. and EU (EU trade name: Xiapex) for
Dupuytren's Contracture (DC).
The phase II study will evaluate the safety and efficacy of
Xiaflex for the treatment of stage II (frozen stage) unilateral
The phase II study will enrol approximately 300 adult men and
women at approximately 35 sites in the U.S. and Australia. The
study will randomize the subjects in the ratio of 3:1 to receive
Xiaflex or placebo. These subjects will receive up to three
ultrasound-guided injections of Xiaflex. The primary endpoint is
the change (degrees) from baseline to the day 95 follow-up visit
in active forward flexion in the affected shoulder compared to
We remind investors that Xiaflex was approved earlier in the
month for an additional indication of Peyronie's disease (PD) in
men with a palpable plaque and a curvature deformity of 30
degrees or greater at the start of therapy.
Xiaflex has been granted Orphan Drug Designation in the U.S.
by the Food and Drug Administration (FDA) for DC and PD.
Auxilium has two FDA approved products in its portfolio -
Testim and Xiaflex. Testim (1% testosterone) is approved for the
treatment of hypogonadism or low testosterone level.
We are encouraged by Auxilium Pharma's efforts to expand
Xiaflex's label. The approval of other indications for Xialflex
will lower Auxilium Pharma's dependence on Testim. The Actient
acquisition earlier this year, the full promotional launch of
Stendra in January, and the recent approval of Xiaflex for PD
will help strengthen the company's position in the men's
Auxilium Pharma currently carries a Zacks Rank #2 (Buy). Some
better-ranked stocks in the same sector include
Questcor Pharmaceuticals, Inc
). Both are Zacks Rank #1 (Strong Buy) stocks.
AUXILIUM PHARMA (AUXL): Free Stock Analysis
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