FORWARD-1 (Focused On Results With A Rethinking of Depression), a part of the comprehensive FORWARD Phase 3 program, aimed to evaluate the safety and tolerability of two titration schedules (1-week and 2-week dose escalation) of ALKS 5461 (n=66). The study also evaluated its efficacy over an 8-week period vs. baseline in patients with MDD.
Study data showed that ALKS 5461 was generally well tolerated in both titration schedules. The safety and tolerability profiles were consistent with the Phase 2 study (n=142) that ended in 2013. In other exploratory efficacy analyses, ALKS 5461 showed a clinically meaningful and statistically significant reduction in depressive symptoms from Week 1 through Week 8 in patients who received either of the two titration schedules (P<0.001). These results support the 1-week titration schedule that is being used in the core Phase 3 efficacy studies in FORWARD.
ALKS 5461 is a once-daily, oral investigational agent that acts as a balanced neuromodulator in the brain representing a novel mechanism of action in the treatment of MDD.
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