Auxilium Pharmaceuticals has reported the results from the Phase 2b clinical trial of Xiaflex (collagenase clostridium histolyticum or CCH), used for the nonsurgical treatment of Peyronie’s disease.
In the randomised, double-blind, placebo-controlled Phase 2b study, 145 patients were monitored for the safety and efficacy of Xiaflex when administered two times a week, every six weeks for up to three treatment cycles, to subjects with Peyronie’s disease.
The trial was designed to measure efficacy endpoints of improvement in penile curvature deformity and improvement in patients’ psychological and physical symptoms using the company’s Peyronie’s disease questionnaire (PDQ).
Patients administered with Xiaflex demonstrated a considerable change compared to placebo at 36 weeks, in both improvement in penile curvature deformity and the PDQ bother domain in the phase 2b study.
The company hopes that the PDQ has been validated for use in its Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies (IMPRESS) Phase 3 trials, following the Phase 2b trial and end of Phase 2 discussions with the US Food and Drug Administration (FDA).
James Tursi, Auxilium chief medical officer, said the aim of the company is to provide an effective and well-tolerated solution for physicians and their patients with the troubling disease.
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"We expect that the pivotal Phase 3 data from our IMPRESS trials, anticipated later this quarter, will continue to expand our knowledge of the treatment of this disease and hopefully will lead to an FDA-approved treatment that may help patients who have few, if any, effective options," Tursi added.
IMPRESS investigator and clinical faculty member of UCLA School of Medicine Division of Urology, Martin Gelbard, said that attaining a considerable reduction in penile curvature deformity and improvement in Peyronie’s disease bother without the risks of surgical intervention, marks an advantage for eligible patients suffering from Peyronie’s disease.
Auxilium plans to file a supplemental Biologics License Application (sBLA) with the FDA, if the Phase 3 IMPRESS results are positive, by the end of 2012.