Purdue NDA For Oxycodone/Naloxone Combo Tests New FDA Policy
This article was originally published in The Pink Sheet Daily
The sponsor believes its data package could support a labeling claim that the drug “is expected to result in a meaningful reduction in abuse”; the agency’s review could indicate the strength of data needed to support such a claim.
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Abuse-deterrent opioids address a serious unmet need and help differentiate brands from the field of generics, but so far Purdue’s OxyContin remains the only opioid on the market with abuse-deterrent claims, even though FDA recently approved two new opioid analgesics.
Generic manufacturer could begin selling either its own product or an authorized generic of the controlled-release opioid as early as Jan. 1, 2016.
Extended-release oxycodone product has potential for broader abuse-deterrent claims than OxyContin; Pfizer expects to resubmit Remoxy to FDA by mid-2015.