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‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA

 
• By Kate Rawson

Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.

Purdue Pharma LP has submitted all required post-marketing studies on the real-world use of OxyContin (extended-release oxycodone) to the US Food and Drug Administration and the data are once again under review.

That was a surprising bit of news to come out of the 15 January Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Advisory Committees’ consideration of Intellipharmaceutics International Inc.’s proposed abuse-deterrent formulation of extended-release oxycodone (known as Aximris XR). That application was overwhelmingly voted down by the joint committee

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