Auxilium Pharmaceuticals announced new data from its Phase 3 IMPRESS trials that evaluated Xiaflex (collagenase clostridium histolyticum [CCH]) for the treatment of Peyronie’s disease (PD) at the 2014 Annual Meeting of the American Urological Association (AUA).

Some of the presented data analyses include:

  • 75% of men with PD treated with Xiaflex in the IMPRESS pivotal studies had a clinically meaningful improvement in their penile curvature deformity by the end of the trials, reporting an improvement of >25% in penile curvature deformity.
  • Xiaflex preferentially degraded type I and type III collagen, predominant collagen types in PD plaques, while sparing type IV collagen present within connective tissues that surround arteries, large veins and nerves.
  • An injection simulator using a “smart syringe” was developed to provide clinicians an opportunity to practice the Xiaflex injection technique.
  • The administration of a 2nd Xiaflex injection 1, 2 or 3 days after the first injection during treatment Cycle 1 did not impact the safety or effectiveness of Xiaflex in the treatment of Peyronie’s curvature deformity evaluated at Week 6.

RELATED: FDA Accepts sBLA for Xiaflex for Concurrent Treatment of Multiple Palpable Cords

Xiaflex is a biologic that was approved for the treatment of Dupuytren’s contracture with a palpable cord and Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

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