FDA Advisory Committees Reject Opioid-Based Depression Drug

A pair of FDA advisory committees has rejected the New Drug Application for ALKS 5461. ALKS 5461 is a combination of buprenorphine and samidorphan being developed by Alkermes as an adjunctive treatment for treatment-resistant major depressive disorder (MDD).

Earlier this month, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 21-2 that the benefit-risk profile of ALKS 5461 was not adequate to support approval. The committees also voted 20-3 that Alkermes did not provide “substantial evidence” to support the efficacy of ALKS 5461.

The NDA submission for ALKS 5461 included efficacy and safety data from more than 30 clinical trials and over 1,500 MDD patients. The results of two large phase 3 trials for ALKS 5461 were recently published in Molecular Psychiatry.

The committees’ recommendation is not binding but will be considered when the FDA does its full review of the NDA for the medication. ■