Alkermes' MDD candidate heads for FDA submission

Alkermes plc (NASDAQ:ALKS) plans to submit an NDA next half for ALKS 5461 as adjunctive treatment of major depressive disorder. The candidate combines samidorphan (ALKS 33), which is a mu opioid receptor (OPRM1; MOR) antagonist, with buprenorphine.

In October, the higher of two doses of ALKS 5461 met the primary endpoint of the Phase III FORWARD-5 trial. The candidate had failed in two previous Phase III studies, which had different primary endpoints than FORWARD-5 (see BioCentury, Nov. 7, 2016)...