New meta-analysis shows benefits of Xiaflex (Auxilium Pharmaceuticals) for Peyronie's disease
A meta-analysis of Phase III results assessing Xiaflex (clostridial collangase for injection), from Auxilium Pharmaceuticals, for the treatment of Peyronie's disease provides new results on previous IMPRESS studies' co-primary and secondary endpoints. Post-hoc meta-analysis from a combination of identical IMPRESS I and II studies indicates that the co-primary endpoints maintain statistical significance. In addition, the % of global responders, the improvement in IIEF overall satisfaction domain, the improvement in Peyronie's disease physical and psychological symptom domain and improvement in penile plaque consistency all met statistical significance, compared to placebo, based on the multiple comparison algorithm within the meta-analysis. However, improvement in penile length and penile pain were not statistically different from placebo.
The most common adverse events were hematoma, pain and swelling. Results are published in the Journal of Urology. See: "Clinical efficacy, safety, and tolerability of collagenase clostridium histolyticum in the treatment of Peyronie�s disease from 2 large double-blind, randomized, placebo�controlled Phase III studies." Martin Gelbar et al. Journal of Urology published online 01 February 2013. doi:10.1016/j.juro.2013.01.087
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