Post-hoc analysis of Xiaflex/Xiapex for Peyronie's Disease reported - Auxilium
Auxilium Pharmaceuticals and Swedish Orphan Biovitrum AB announced that data were presented from multiple clinical trials evaluating the use of Xiaflex/Xiapex (collagenase clostridium histolyticum or CCH) in adult patients with Peyronie's disease (PD). A post-hoc analysis of the pooled data from the IMPRESS I and II Phase III trials showed improved clinical outcomes following CCH-treatment regardless of subjects' baseline PD treatment history, erectile function scores, and/or prostatectomy history. The global safety analysis of seven clinical trials of CCH for the treatment of PD shows that the adverse events were mostly localized to the penis, non-serious and resolved without intervention before the next injection.
Serious adverse events (SAEs) related to treatment were also all localized to the penis in these clinical studies. A total of 60 (5.7%) of CCH-treated subjects experienced at least one treatment-emergent SAE, nine of whom experienced treatment-related SAEs (five penile hematoma and four corporal rupture). The data were presented at the 29th Annual European Association of Urology (EAU) Congress.
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