PTI’s Remoxy: Negative FDA Panel Review May Be The End Of Abuse-Deterrent Opioid's Road

Concerns that the extended-release oxycodone product poses the same potential for intravenous abuse as Endo’s withdrawn Opana ER drive FDA advisory committee recommendation against approval, laying the groundwork for a fourth complete response letter; FDA’s comparison of Remoxy to Opana during the meeting ‘borders on slanderous,’ PTI CEO Barbier tells Scrip, predicting sponsors will be dissuaded by the shifting regulatory goalposts for abuse-deterrent formulations.

Concerns about Remoxy's similarities to Endo's now-withdrawn Opana ER could mean the end of the long-acting opioid's development.