OxyContin Abuse Deterrent Formulation Voted Beneficial By FDA Panel, But Questions Remain
Label change is one option after US advisory committee review of Purdue’s postmarketing studies concludes reformulated OxyContin ‘meaningfully reduced abuse’ by non-oral routes, but finds there is not evidence to show such reduction via all routes or that ADF reduced risk of opioid overdose.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Meeting to address opioid abuse crisis was also a trial of whether FDA could conduct important public business using online-only technology.
FDA says it is unclear whether Purdue’s OxyContin abuse deterrent reformulation reduced opioid overdoses or had a net public health benefit. Briefing document for upcoming advisory committee meeting asks panel to discuss Purdue’s four postmarket studies but does not include voting question on possible change in labeling claims.