What's Missing In Intellipharmaceutics' Opioid Filing? FDA Panel Offers List

Advisory committee notes missing pieces in sponsor's data for abuse-deterrent oxycodone extended release opioid; excipients to deter abuse also need toxicity testing.

Prescription Opiate and Heroin Abuse

During an advisory committee review of its application for Rexista (oxycodone extended-release), Intellipharmaceutics International Inc. was unable to answer numerous questions about the safety and efficacy of the opioid, prompting panelists to question why the company had filed an application with limited data.

The committee's July 26 discussion provided a blueprint of sorts on what the company should do as it will likely have to go back to the drawing board to conduct more studies – and also

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