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: 31 Jan 2018
At a glance
- Drugs Buprenorphine/samidorphan (Primary)
- Indications Major depressive disorder
- Focus Registrational; Therapeutic Use
- Acronyms FORWARD-4
- Sponsors Alkermes plc
- 31 Jan 2018 According to Alkermes media release, based on the data from more than 30 clinical trials and more than 1,500 patients with major depressive disorder, the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD).
- 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.