Auxilium Pharmaceuticals reports interim data from XIAFLEX Phase 4 study in patients with DC

Published on January 9, 2014 at 3:17 AM · No Comments

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company, today announced that interim data from its Phase 4 retreatment study (AUX-CC-862) evaluating XIAFLEX® (collagenase clostridium histolyticum or CCH) in adult patients with Dupuytren's contracture (DC) and a recurrent contracture with a palpable cord will be presented for the first time at the American Association for Hand Surgery (AASH) 2014 Annual Meeting being held January 8-11, 2014 in Kauai, Hawaii. XIAFLEX is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX has been granted Orphan Drug Designation in the U.S. by the FDA for DC and PD.

This open-label Phase 4 study is evaluating 51 patients who had recurrence of a contracture (an increase of >20 degrees as well as a palpable cord) in a joint that had been previously effectively treated with XIAFLEX (resulting in contracture of <5 degrees). Patients were treated with up to three injections of XIAFLEX (28 days apart) to the recurrent cord and were then evaluated for clinical outcome, changes in contracture and range of motion, physician assessment of improvement, patient satisfaction and safety. This interim analysis was conducted after all patients had completed their 30-day follow up assessments.

Key Data Highlights:

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