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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of EN3835 In The Treatment Of Edematous Fibrosclerotic Panniculopathy (Cellulite)

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of EN3835 In The Treatment Of Edematous Fibrosclerotic Panniculopathy (Cellulite)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Sep 2021

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At a glance

  • Drugs Collagenase clostridium histolyticum (Primary)
  • Indications Cellulite
  • Focus Registrational; Therapeutic Use
  • Acronyms RELEASE-1
  • Sponsors Endo Pharmaceuticals

    • Most Recent Events

    • 13 Apr 2021 According to an Endo International media release, data published in Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery.
    • 06 Jul 2020 According to an Endo International media release, the U.S. Food and Drug Administration (FDA) approval of Qwo (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women.
    • 19 Nov 2019 According to an Endo International media release, based on the RELEASE-1 and RELEASE-2 studies, as well as a robust clinical and pre-clinical program, the U.S. Food and Drug Administration (FDA) has accepted for review the original Biologics License Application (BLA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks. The Prescription Drug User Fee Act (PDUFA), or target action date for the BLA, has been set for July 6, 2020.

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