Any chance left for safer opioids?
Chances for safer opioids have nosedived with recent FDA and payer track records
The future is looking bleak for new opioids. Between a pair of advisory committee meetings this month that delivered two blows to abuse-deterrent candidates, and the discontinuation of at least half of the newest market entrants, the odds are getting longer for success, meaning investment in the class could well dry up.
Any hope for new opioids will require a shift in guidelines and expectations among both regulators and payers, not to mention major scientific innovation.
On Jan. 14 and 15, joint panels of FDA’s Analgesic Drug Products and Drug Safety and Risk Management adcomms shot down oxycodegol (NKTR-181) from Nektar Therapeutics (NASDAQ:NKTR) and Aximiris XR from Intellipharmaceutics International Inc. (NASDAQ:ICP; TSX:IPCI).
Panelists voted unanimously (0-27) against oxycodegol to treat chronic lower back pain or as a general long-acting analgesic for chronic pain indications, and rebuffed Aximiris XR for moderate to severe pain in a 2-24 vote.
The outcome of the two votes, coupled with earlier votes against other opioids, have sent a clear signal to drugmakers and investors -- new opioids stand little chance of making it through an adcomm.
To be clear, both products had problems with the trial designs and results that make them far from the best test cases for how safer opioids can fare. But their fate fits a pattern of an ever-rising bar for both regulatory and commercial success.