Alkermes plc announced that “Molecular Psychiatry” has published phase 3 clinical data for ALKS 5461, a once-daily, oral investigational medicine that acts as an opioid system modulator and represents a novel mechanism of action for the adjunctive treatment of major depressive disorder, or MDD, in patients with an inadequate response to standard antidepressant therapies. The Molecular Psychiatry publication includes comprehensive efficacy and safety results from the FORWARD-4 and FORWARD-5 studies and a review of a pooled analysis of the two datasets. Collectively, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD, the company stated. The New Drug Application for ALKS 5461 is currently under U.S. Food and Drug Administration review, with a FDA Advisory Committee meeting scheduled on Nov. 1, 2018 and a target action date of Jan. 31, 2019.
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