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Where Is OxyContin Abuse Deterrent Data? Purdue Has Sent Two Studies, But Wait Continues

 
• By Brenda Sandburg

US FDA expects to receive two more postmarket studies this year, but Purdue has not yet decided if it will resubmit a supplemental NDA. Consortium of 13 companies have completed six additional studies on extended-release opioids.

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US FDA advisory committees reviewing abuse-deterrent formulations of opioids have repeatedly asked one question: where is the evidence to show these formulations work in the real world? Specifically, they wonder when Purdue Pharma LP will submit postmarket data on its abuse deterrent formulation of OxyContin (oxycodone extended-release), the first opioid to be approved with properties to deter abuse.

The question came up again during the Nov. 14 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, which was held...

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