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STRIDE-1: A Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of AXS-05 Administered Orally to Subjects With Treatment Resistant Major Depressive Disorder

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Trial Profile

STRIDE-1: A Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of AXS-05 Administered Orally to Subjects With Treatment Resistant Major Depressive Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 May 2022

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At a glance

  • Drugs Bupropion/dextromethorphan (Primary) ; Bupropion
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms STRIDE-1
  • Sponsors Axsome Therapeutics

Most Recent Events

  • 02 May 2022 According to an Axsome Therapeutics media release, the Company anticipates potential FDA action on the NDA in the second quarter of 2022.
  • 05 Nov 2020 According to an Axsome Therapeutics media release, the company now expects to submit the NDA in January instead of by year-end.
  • 13 Jul 2020 According to an Axsome Therapeutics media release, the company has completed a successful pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for AXS-05 for the treatment of major depressive disorder (MDD). Based on the feedback from the FDA, the Company believes its regulatory data package will be sufficient to support an NDA for AXS-05 in MDD, and Axsome remains on track to submit the planned NDA in the fourth quarter of 2020.

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