Depression drug taken forward despite trial failures

23 August 2017

Alkermes (Nasdaq: ALKS) will hope that the US Food and Drug Administration (FDA) ignores the failure of two Phase III studies to reach their primary endpoints, on considering the New Drug Application (NDA) for the company’s depression candidate, ALKS 5461.

The US CNS specialist has announced the initiation of its rolling submission of an NDA for its once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder (MDD).

ALKS 5461 has received Fast Track designation from the FDA but it also failed to show a significant improvement on placebo in improving depression symptoms, the primary endpoints of the FORWARD-3 and FORWARD-4 trials.

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