US FDA Strategy On Abuse-Deterrent Opioids Needs Rethinking, Panelists Say
Deterring intravenous abuse over other routes of abuse should be agency's priority, some advisory committee members say during discussion of abuse patterns and risks with Endo’s reformulated Opana ER.
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She is as polarizing as she is powerful, but whether you think Janet Woodcock is drug development’s hero or public health’s enemy, there’s no denying she dramatically transformed the US FDA over her 35-year career.
US FDA will survey health care providers’ current understanding of analgesic abuse-deterrent formulations and conduct an experimental study exploring the effectiveness of different terminology and descriptions for such products; agency has heard complaints from its own AdComms about terminology around abuse deterrence.
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.