Purdue Abuse Study May Create Ongoing Challenge For Generic Entry
This article was originally published in The Pink Sheet Daily
OxyContin’s three-year data exclusivity for study of intranasal liking might be just the beginning of labeling hurdles for ANDAs.
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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.
There will be no generics of original OxyContin; FDA says it can no longer serve as a reference product because it has a greater abuse potential than the reformulation, where Purdue has secured particularly strong language regarding reducing intranasal abuse.
CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.