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

 
• By Sue Sutter

Concerns that the extended-release oxycodone product poses the same potential for intravenous abuse as Endo’s withdrawn Opana ER drive FDA advisory committee recommendation against approval, laying the groundwork for a fourth complete response letter; FDA’s comparison of Remoxy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.

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Concerns about Remoxy's similarities to Endo's now-withdrawn Opana ER could mean the end of the long-acting opioid's development.

Pain Therapeutics Inc. is standing on the verge of a regulatory dead-end for Remoxy (oxycodone extended-release) following a US FDA advisory committee’s negative review June 26, and the company's CEO warns that the "changing goalposts" might deter future development in the abuse-deterrent opioid space. 

The committee’s 14-3 vote against approval suggests the long-acting opioid formulated with abuse-deterrent properties is headed for its fourth complete...

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