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.
You may also be interested in...
Pfizer’s Embeda Joins Abuse-Deterrent Club, But FDA Wants Assurances
As with Purdue’s Targiniq, agency requires a post-marketing study to determine whether the new morphine/naltrexone formulation actually deters abuse.
Abuse-Deterrence Among New GDUFA Regulatory Science Priorities
FDA says it will need tools to evaluate technologies designed to deter nasal abuse in generics.
No OxyContin Comparison? Then No Priority Review For Targiniq ER
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.