ALKS 5461: Phase III data

Top-line data from the double-blind, international Phase III FORWARD-4 trial in 385 MDD patients who had an inadequate response to a stable dose of either a selective serotonin reuptake inhibitor (SSRI) or a serotonin/norepinephrine reuptake inhibitor (SNRI) showed that both doses of once-daily oral ALKS 5461 (0.5 mg each of samidorphan and buprenorphine and 2 mg each of samidorphan and buprenorphine) as adjunctive treatment missed the primary endpoint of improving MADRS scores from baseline to week 10 vs. placebo. Alkermes said there was a “clear trend toward efficacy” with high-dose ALKS 5461 on the primary endpoint, but declined to disclose details. ...