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An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder

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Trial Profile

An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2022

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At a glance

  • Drugs Bupropion/dextromethorphan (Primary)
  • Indications Major depressive disorder
  • Focus Adverse reactions; Registrational
  • Acronyms COMET
  • Sponsors Axsome Therapeutics

Most Recent Events

  • 09 Aug 2022 According to an Axsome Therapeutics media release, the Company anticipates potential FDA action on the NDA in the third quarter of 2022.
  • 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.
  • 01 Dec 2020 Results presented in an Axsome Therapeutics media release.

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