A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
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-4
- 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, pooled data from FORWARD-4 and FORWARD-5 will be presented at the Society of Biological Psychiatry (SOBP) Annual Meeting.
- 03 Feb 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.