A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)
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-5
- Sponsors Alkermes plc
- 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.
- 11 May 2017 According to an Alkermes media release, data from this trial and pooled data from FORWARD-4 and FORWARD-5 will be presented at the Society of Biological Psychiatry (SOBP) Annual Meeting.
- 31 Oct 2016 Status changed from recruiting to completed.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History