Evaluation of collagenase Clostridium histolyticum for the treatment of Peyronie’s disease

Abstract

Introduction: Peyronie’s disease is characterized by fibrosis of the tunica albuginea, which may lead to significant pain, deformity and/or erectile dysfunction. This is often accompanied by significant psychosocial distress. Modern studies suggest a higher prevalence of disease than previously believed, leading to novel targeted investigational drug therapies for selected patients.

Areas covered: Collagenase Clostridium histolyticum (CCH), comprised of AUX-1 and AUX-2, is the only FDA-approved medical therapy for men with PD with palpable dorsal plaques and curvatures between 30 and 90 degrees. The authors discuss the published pharmacodynamics, safety and efficacy data from the Phase I, Phase II and Phase III studies for CCH.

Expert opinion: CCH can be used as a minimally invasive treatment for reducing penile curvature with a well-tolerated side effect profile. Intralesional injection of CCH with modeling was shown to decrease penile curvature. The most common adverse events include ecchymosis, swelling and pain, requiring close follow-up of treated men. Although major adverse events are rare, corporal rupture and penile hematoma have been reported. Major limitations of CCH include cost and work-time loss. Longer term follow-up is needed to assess for safety, durability and efficacy associated with CCH in the post-marketing surveillance period.

Keywords:

• collagenase Clostridium histolyticum
• penile curvature
• penile plaque
• Peyronie’s disease
• Peyronie’s disease questionnaire

Declaration of interest

Dr. Hellstrom – PI, speaker and advisory board for Auxilium/Endo Pharmaceuticals. All other authors declare no conflicts. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.