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Opioids: Intellipharmaceutics' Pursuit Of IV-Only Deterrence Claim May Backfire

 
• By Sue Sutter

US FDA advisory committee may not be comfortable with intravenous abuse-deterrence labeling for Rexista (oxycodone extended-release) when the sponsor has not assessed the impact on other routes of abuse purportedly targeted by the formulation.

Intellipharmaceutics International Inc. decision to pursue only an intravenous abuse-deterrence labeling for Rexista (oxycodone extended-release) could prove problematic for a US FDA advisory committee and has the potential to raise the same types of concerns about excipients and shifting routes of abuse that led the agency to seek withdrawal of Endo Pharmaceuticals Inc.'s Opana ER.

FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will convene July 26 to consider the overall risk/benefit profile for Rexista and whether the sponsor has

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