Alkermes ALKS 5461 Misses Mark in Phase 3

Alkermes’ lead candidate ALKS 5461 flopped in two of its three pivotal trials for major depressive disorder, with both trials missing the primary endpoints compared to placebo.

The company is conducting a third efficacy study, and it plans to enroll more patients so that additional data might provide a regulatory path forward for the compound.
In October 2013, the FDA granted fast track status for ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.