Positive data in studies of Xiaflex for Peyronie's disease-Auxilium Pharma

Auxilium Pharmaceuticals has announced data from new studies, as well as new analyses of data from the Phase II and the pivotal Phase III IMPRESS trials evaluating Xiaflex (clostridial collangase for injection) for the treatment of Peyronie's disease (PD). Data were presented from an exploratory analysis of responses evaluating the impact of treatment for PD on the female partner. Improvement in female sexual function was observed as measured by all six domains (scales of desire, arousal, lubrication, orgasm satisfaction, and pain as well as the full scale total scores) of the FSFI score, and FSP sexual dysfunction decreased. A post hoc analysis of the IMPRESS studies suggested that within each PD duration grouping, indicating patients with PD for 6-12 months, Xiaflex demonstrated statistically significant mean percent improvement in penile curvature deformity compared to placebo. An increased placebo effect was also observed in patients with PD duration of 6 to 12 months.

Study results suggest that further study of Xiaflex treatment in the early months of PD should be considered. Encore data from the IMPRESS studies assessing patient quality of life were presented suggesting that improvements in penile curvature deformity after treatment with Xiaflex result in clinically meaningful improvements in symptoms. Finally a post hoc analysis of the IMPRESS studies provided further evidence that PD bother is clinically significant and may be a useful measure in clinical practice when treating PD. Data were presented at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America.