ALKS 5461: Phase III data
Top-line data from the double-blind, international Phase III FORWARD-5 trial in 407 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 met the primary endpoint of improving MADRS-6 scores from baseline to week 11 vs. placebo (p=0.018). Scores were calculated by averaging the mean changes from weeks 3-5 and 8-11. Low-dose ALKS 5461 (1 mg each of samidorphan and buprenorphine) missed the primary endpoint vs. placebo. High-dose ALKS 5461 also significantly improved 10-item MADRS (MADRS-10) scores from baseline to week 11 vs. placebo (p=0.026). ALKS 5461 was generally well tolerated with nausea, dizziness and fatigue reported as the most common adverse events...