Positive Safety, Tolerability Data for ALKS 5461 in MDD Study

Alkermes announced positive results for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD).

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.

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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.

For more information visit Alkermes.com.

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