FDA advisory panel votes against Alkermes depression drug ALKS-5461 approval

The Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the US Food and Drug Administration (FDA), yesterday reviewed Alkermes (Nasdaq: ALKS) New Drug Application (NDA) for ALKS-5461 (buprenorphine/samidorphan).

The committee jointly voted that the benefit-risk profile was not adequate to support approval (Vote: 2 Yes/ 21 No), meaning that the FDA’s formal decision is unlikely to be different. Panelists also voted 20 to 3 that Alkermes hasn’t provided substantial evidence that the drug is effective.

ALKS-5461 is a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies.