Posted by Michael Wonder on 06 Aug 2018
Complete response letter issued for Remoxy
6 August 2018 - Pain Therapeutics today announced it had received a complete response letter from the U.S. FDA for its new drug application 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."
“This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction,” said Remi Barbier, President & CEO. “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.”
