Pain Therapeutics receives CRL from FDA for Remoxy
Pain Therapeutics announced it had received a Complete Response Letter, or CRL, from the FDA for its New Drug Application, or NDA, for Remoxy, an abuse-deterrent, extended-release form of oxycodone. According to FDA, "The data submitted in [the] NDA do not support the conclusion that the benefits of Remoxy Extended-Release Capsules outweigh the risks." Remi Barbier, President & CEO said, "This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction. We have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin. We relied on the criteria of a fair, neutral and impartial regulatory review, as any sponsor would. Instead, I believe Remoxy received an ideological judgement call that is vague in nature but conclusive in its damaging effects."