Alkermes Depression Drug Faces Tough Questions At US FDA Advisory Committee
If approved, ALKS 5461 would be first opioid-containing product to carry indication for depression; Alkermes CEO Pops tells Pink Sheet that agency's safety and efficacy concerns are surmountable because "all depression drugs have mixed results."
You may also be interested in...
The latest drug development news and highlights from our US FDA Performance Tracker.
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.
US FDA accepts Alkermes' NDA for depression drug after issuing refuse-to-file letter just two weeks ago; unusual move falls outside agency's guidance on RTFs because no changes were made to submission and it wasn't filed over protest.