Abuse-Deterrent Opioids: Rexista To Test New FDA Leadership's Approach
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.
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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.
Data sources and methodologies to evaluate real-world effects of abuse-deterrent formulations will be focus of US FDA public meeting in July; value and feasibility of assessing the public health effects of such products more broadly is up for discussion.
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