Auxilium Pharmaceuticals, Inc. (AUXL) recently dosed its first patient for the phase II study on Xiaflex for the treatment of frozen shoulder syndrome (FSS or adhesive capsulitis).
We note Xiaflex, in-licensed from BioSpecifics Technologies Corp. (BSTC), 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 idiopathic FSS.
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 placebo.
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 healthcare area.
Auxilium Pharma currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the same sector include Forest Laboratories (FRX) and Questcor Pharmaceuticals, Inc. (QCOR). Both are Zacks Rank #1 (Strong Buy) stocks.