FDA reviewers question efficacy, abuse liability of Alkermes antidepressant

In briefing documents issued ahead of an advisory committee meeting, FDA reviewers expressed multiple concerns about efficacy analyses performed in studies of ALKS 5461 from Alkermes plc (NASDAQ:ALKS) to treat major depressive disorder (MDD), as well as broader concerns about the safety of opioid treatment of depression.

The agency's Psychopharmacological Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee are to discuss an NDA for the therapy on Thursday in a joint meeting...