Phase 3 Study Update of Xiaflex for Peyronie's Disease
Auxilium Pharmaceuticals announced positive results from its two Phase 3 IMPRESS trials that assessed Xiaflex (collagenase clostridium histolyticum or CCH) for the potential treatment of Peyronie's disease (PD). Mean reduction in penile curvature and improvement in Peyronie's disease, the two primary endpoints, showed statistical significance.
Two randomized, double-blind, placebo-controlled Phase 3 studies enrolled over 800 patients at 64 sites in the US and Australia with a 2:1 ratio of Xiaflex to placebo. In IMPRESS I (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for Xiaflex subjects (P=0.0005) and a 3.3 point (44%) improvement in the Peyronie's Disease Questionnaire (PDQ) bother domain for XIAFLEX subjects (P=0.0451). In IMPRESS II at 52 weeks, the co-primary endpoints met statistical significance with a 30.5% mean improvement in penile curvature deformity for XIAFLEX subjects (P=0.0059) and a 2.4 point (32.4%) improvement in the PDQ bother domain for XIAFLEX subjects (P=0.0496).
Xiaflex is a collagenase combination biologic indicated for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord. Xiaflex has been granted orphan drug status by the FDA.
For more information call (877) 663-0412 or visit www.auxilium.com.