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Alkermes' Depression Drug Likely Needs Another Trial After Crushing US Advisory Cmte. Vote

 
• By Michael Cipriano

Nearly every panelist cited lack of substantial evidence of efficacy in voting against approval of ALKS 5461, a fixed-dose combination of buprenorphine and samidorphan.

Brain decline and dementia or aging as memory loss concept for brain cancer decay or an Alzheimer's disease with old rusting mechanical gears and cog wheels in the shape of a human head with rust.

Alkermes PLC will likely need to conduct another efficacy trial if it wants to continue to seek approval for its major depressive disorder (MDD) candidate ALKS 5461, as a US FDA advisory panel overwhelmingly voted against the drug's risk/benefit profile by a 21-2 margin at a Nov. 1 meeting.

Members of the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee overall felt the sponsor failed to demonstrate substantial evidence of efficacy, an area which FDA came into the meeting with serious concerns

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