A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

Trial Profile

A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2017

At a glance

  • Drugs Buprenorphine/samidorphan (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms FORWARD-3
  • Sponsors Alkermes plc
  • Most Recent Events

    • 21 Aug 2017 According to Alkermes media release, the company has initiated the submission of the NDA to US FDA for marketing approval of ALKS 5461 for treatment of major depressive disorder (MDD) and expects to complete the submission by year-end 2017.
    • 02 Mar 2016 Status changed from active, no longer recruiting to completed as per the European Clinical Trials Database record.
    • 21 Jan 2016 Primary endpoint (Change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score) has not been met, according to an Alkermes plc media release.
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