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OxyContin Reformulation Reduced Abuse Via Non-Oral Routes But Not Overall Abuse, US FDA Finds

 
• By Brenda Sandburg

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.

Oxycontin
FDA finds reformulated OxyContin reduces abuse of the product via non-oral routes

The US Food and Drug Administration’s analysis of postmarket data found that OxyContin’s abuse deterrent formulation has reduced abuse of the opioid through non-oral routes but concluded that there is not robust evidence that it has caused a meaningful reduction in overall abuse.

The agency analyzed four postmarketing studies conducted by Purdue Pharma L.P. as well as published literature in considering the...

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