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Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder

Trial Profile

Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Dec 2023

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At a glance

  • Drugs Bupropion/dextromethorphan (Primary) ; Bupropion
  • Indications Major depressive disorder
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASCEND
  • Sponsors Axsome Therapeutics
  • Most Recent Events

    • 11 Dec 2023 Results of pooled post hoc analysis (from studies GEMINI and ASCEND) presented in the Axsome Therapeutics Media Release
    • 19 Aug 2022 According to an Axsome Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved AUVELITYTM (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. Company anticipates AUVELITY to be commercially available in the U.S. in the fourth quarter of 2022.
    • 18 May 2022 According to an Axsome Therapeutics media release, Dan Iosifescu, MD, Professor of Psychiatry at the New York University School of Medicine, Director of the Clinical Research Division at the Nathan Kline Institute for Psychiatric Research, is a co-author of the recent publication
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