Purdue's reformulated OxyContin gets US panel backing on second try
This article was originally published in Scrip
Purdue Pharma's reformulated OxyContin (oxycodone extended-release) may be less susceptible to abuse and manipulation than the currently marketed version, but risk management plans and postmarketing studies will be critical to determining whether the formulation is actually safer, the US FDA's outside experts have said.
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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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