Pain Therapeutics endures yet another FDA slapdown on Remoxy — time to call it quits?
The pain just won’t stop for Pain Therapeutics $PTIE.
A panel of outside experts at the FDA today slapped down their latest attempt to get Remoxy ER over the finish line and into the market. But operating in a field where vigilance over potential abuse has reached a fever pitch, the majority of the panel turned thumbs down.
The vote was 14 against approval, only 3 for.
That is not necessarily a death sentence on the pitch, but it comes close. The biotech’s stock was eviscerated in after-market trading, dropping 72% in an extinction-level event.
Pfizer once gambled big on this program, believing that its tamper-resistant approach could win over regulators. But the pharma giant threw in the towel way back in 2014 after the FDA persuaded them that plenty of doubts still remained,
Close to two years ago Pain Therapeutics was delivered its third rejection for this treatment. Another seems likely now. For a micro-cap biotech, the regulatory position seems clear.
FDA ADCOMM VOTE: Based on the data presented and the discussions about the data, do the efficacy, safety and risk-benefit profile of #RemoxyER support the approval of this application?
— SAC Tracker (@FDAadcomm) June 26, 2018