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Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

The joint committee met to discuss the efficacy, safety, and risk-benefit profile of the new drug application (NDA) for ALKS-5461 (buprenorphine and samidorphan sublingual tablets), submitted by Alkermes, Inc. (Alkermes), for adjunctive treatment of major depressive disorder (MDD).

A majority of the joint committee, 21 of 23 members, voted that the available data do not support a favorable benefit-risk profile of ALKS-5461 to support its approval. Two of 23 joint committee members voted that the available data do support its approval.