DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today announced the initiation of the pivotal clinical development program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD). The comprehensive pivotal program, named FORWARD (Focused On Results With A Rethinking of Depression), includes a total of 12 studies, including three core phase 3 efficacy studies and nine supportive studies. The first FORWARD study, evaluating the onset of clinical effect, safety and tolerability of ALKS 5461 in approximately 60 patients with MDD, has begun, and the three core efficacy studies are expected to begin in mid 2014.
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