An Open-label Study Assessing Long-term Safety of DRM04 in Subjects With Primary Axillary Hyperhidrosis

Trial Profile

An Open-label Study Assessing Long-term Safety of DRM04 in Subjects With Primary Axillary Hyperhidrosis

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2017

At a glance

  • Drugs Glycopyrrolate (Primary)
  • Indications Hyperhidrosis
  • Focus Adverse reactions; Registrational
  • Acronyms ARIDO
  • 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 Oct 2017 Results presented in a Dermira media release.
    • 13 Oct 2017 Results from this trial were presented at the 36th Annual Fall Clinical Dermatology Conference, according to a Dermira media release.
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