FDA Shoots Down Alkermes’ Depression Medication

Alkermes received a Refusal to File letter from the FDA regarding its new drug application for ALKS 5461, an investigational medicine designed to treat depression when standard antidepressant therapies are insufficient.

The agency determined it could not complete its evaluation of the regulatory package due to insufficient evidence of effectiveness.

The agency called for additional well-controlled clinical trials before the NDA can be resubmitted, and requested a bioavailability study to generate additional bridging data between Alkermes’ medication and the reference listed drug, buprenorphine.