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Intellipharmaceutics’ Oxycodone ER Returns To US FDA Panel Looking For Abuse-Deterrence Claim

 
• By Sue Sutter

Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.

Addict man make injection of drugs
Aximris XR can be expected to have some deterrent effect by the intravenous route of abuse, the FDA says. • Source: Shutterstock

A US Food and Drug Administration advisory committee on 15 January will be asked to weigh whether approval is warranted for Intellipharmaceutics International Inc.’s reformulated oxycodone extended-release product when the evidence supports deterrence by only one of three routes of abuse.

Members of the anesthetic and analgesic drug products and drug safety and risk management advisory committees will discuss whether Intellipharmaceutics...

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