A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of DRM04 in Subjects With Axillary Hyperhydrosis

Trial Profile

A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of DRM04 in Subjects With Axillary Hyperhydrosis

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2017

At a glance

  • Drugs Glycopyrrolate (Primary)
  • Indications Hyperhidrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ATMOS-1
  • Sponsors Dermira
  • Most Recent Events

    • 06 Nov 2017 According to a Dermira media release, the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for glycopyrronium tosylate (formerly DRM04) and completed its filing review. The Prescription Drug User Fee Act target date for the completion of the FDA's review of the NDA is June 30, 2018.
    • 13 Sep 2017 Results from ATMOS-1 and ATMOS-2 trials published in a Dermira media release.
    • 07 Sep 2017 According to Dermira media release, data from two phase III (ATMOS-1 & ATMOS-2) studies will be presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress
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