CHESTERBROOK, Pa., Feb. 1, 2013 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that The Journal of Urology has electronically published the uncorrected proof of the Company's pivotal IMPRESS (The I nvestigation for M aximal P eyronie's R eduction E fficacy and S afety S tudies) trials, the phase III studies that assessed XIAFLEX ® (collagenase clostridium histolyticum or CCH), a novel, in-office, biologic for the potential treatment of Peyronie's disease (PD) on its website www.jurology.com. The article may be found at http://www.jurology.com/article/S0022-5347(13)00227-9/abstract. The manuscript is currently scheduled to appear in print in the July 2013 print version of The Journal of Urology.
Auxilium has previously announced positive top line efficacy and safety results of the IMPRESS studies' co-primary endpoints. In IMPRESS I and IMPRESS II at 52 weeks, both co-primary endpoints met statistical significance for mean percent improvement in penile curvature deformity and mean improvement in the PDQ bother domain for XIAFLEX subjects vs. placebo patients. Additionally, XIAFLEX was generally well-tolerated. If approved by the U.S. Food and Drug Administration (FDA), XIAFLEX is expected to be the first approved biologic indicated for the treatment of PD.
"We believe that XIAFLEX, if approved for the treatment of Peyronie's Disease, has the clinical profile to become a potential breakthrough treatment," said Adrian Adams, Auxilium's Chief Executive Officer and President. "With its current indication in Dupuytren's contracture, positive clinical results in Peyronie's disease, and development ongoing in Frozen Shoulder syndrome and Cellulite, CCH represents a pipeline in a product with potential applications in multiple therapeutic areas that currently have limited treatment options."Today's publication includes details of the co-primary and secondary families of endpoints. Statistical significance for the co-primary endpoints and two families of secondary endpoints was determined by a multiple comparison algorithm based on gate keeping strategies designed to control the overall family-wise type 1 error rate to be less than or equal to 0.05. In IMPRESS I and II individually, the two co-primary endpoints each required a p-value less than or equal to 0.05, while the algorithm for the first family of secondary endpoints was equivalent to requiring a p-value less than or equal to 0.0167 and the algorithm for the second family required a p-value less than or equal to 0.0042. In both IMPRESS I and II, first family secondary endpoints (improvement from baseline in percentage of global responders, PDQ psychological and physical symptoms, and IIEF (International Index for Erectile Function) overall satisfaction) and second family secondary endpoints (percentage of composite responders, improvement in penile length, plaque consistency, and penile pain) were measured in CCH-treated men compared with placebo.
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