ALKS 5461: Phase III data

Top-line data from the double-blind, international Phase III FORWARD-3 trial in 429 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 once-daily high-dose oral ALKS 5461 (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 that no treatment effect of ALKS 5461 was observed. ...