A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for Up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease.

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Trial Profile

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for Up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease.

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Oct 2017

At a glance

  • Drugs Collagenase clostridium histolyticum (Primary)
  • Indications Peyronie's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms IMPRESS-I
  • Sponsors Auxilium Pharmaceuticals

    • Most Recent Events

    • 19 May 2015 Results presented at the American Urological Association (AUA) at its 110th Annual Scientific Meeting, as reported by Endo Pharmaceuticals media release.
    • 30 Jan 2015 According to a Swedish Orphan Biovitrum AB media release, the EU Commission has approved Xiapex for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
    • 08 May 2014 According to a BioSpecifics Technologies Corporation media release, a MAA of XIAPEX for the treatment of Peyronie's disease is being processed by SOBI (Swedish Orphan Biovitrium AB).
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