OxyContin’s Abuse-Deterrent Claims Strong, But Stronger Claims Possible
FDA reviewed all the categories of pre-marketing and post-marketing data outlined by guidance for abuse-deterrent opioids, but only in vitro and liking studies made it into the updated label.
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As with Purdue’s Targiniq, agency requires a post-marketing study to determine whether the new morphine/naltrexone formulation actually deters abuse.
FDA says it will need tools to evaluate technologies designed to deter nasal abuse in generics.
FDA rejected Purdue’s request for priority review of Targiniq ER because the NDA did not show an improvement in abuse deterrence over the sponsor’s own reformulated OxyContin, but the agency noted advantages to having both formulations available.