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Abuse-Deterrent Opioids: Rexista To Test New FDA Leadership's Approach

 
• By Sue Sutter

Intellipharmaceutics seeks oral, intranasal and intravenous abuse-deterrence claims for Rexista (extended-release oxycodone) when it goes before an advisory committee July 26. Even if it passes muster with the US agency under Commissioner Scott Gottlieb, patent and exclusivity issues could impact market availability and labeling.

Opioid abuse epidemic concept

Intellipharmaceutics International Inc.'s Rexista (oxycodone extended-release) may serve as an early test case for potentially stricter scrutiny from the US FDA – under the leadership of Commissioner Scott Gottlieb – of new abuse-deterrent formulations when the long-acting opioid goes before an advisory committee in late July.

However, even if FDA determines Rexista should be approved with abuse-deterrent labeling, market availability and labeling claims could be delayed...

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