Purdue's Pain And No Gain: More Analysis Of OxyContin Postmarket Studies Needed
This article was originally published in The Pink Sheet Daily
FDA cancels advisory committee once Purdue pulls sNDA, but firm plans to resubmit after 'building the most compelling body of epidemiological evidence' that reformulated product has meaningful impact on abuse.
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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.
Five years after an advisory committee meeting was cancelled, panel will consider whether required postmarketing studies show Purdue’s reformulated opioid ‘meaningfully’ reduces abuse and overdose.
Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.