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A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)

Trial Profile

A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Aug 2019

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At a glance

  • Drugs Buprenorphine/samidorphan (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms FORWARD-5
  • Sponsors Alkermes plc
  • Most Recent Events

    • 01 Feb 2019 According to an Alkermes media release, company received a complete response letter from the US FDA for its NDA for buprenorphine/samidorphan. The CRL stated that the US FDA was unable to approve the NDA in its present form and requested additional clinical data . Company plans to meet with the US FDA to discuss the contents of the CRL and potential next steps.
    • 01 Nov 2018 According to an Alkermes media release, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), met to review the companys New Drug Application (NDA) for ALKS 5461. The committee jointly voted that the benefit-risk profile was not adequate to support approval (Vote: 2 Yes/ 21 No).
    • 01 Nov 2018 According to an Alkermes media release, the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), will meet today to review the New Drug Application (NDA) for ALKS 5461.
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