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Anesthetic and Analgesic Drugs Advisory Committee and Drug Safety and Risk Managment Advisory Committee

On Wednesday, July 26, 2017, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee voted that Rexista (oxycodone extended-release tablets), submitted by Intellipharmaceutics Corp. (Intellipharmaceutics) should not be approved, by a vote of  1-Yes and 22-No.. The proposed indication of Rexista is the management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The Committees also voted in regard to the company’s proposed label claim regarding abuse-deterrence. The FDA’s decision goal date for the Rexista New Drug Application (NDA) is September 25, 2017.

Tarius note: Rexista is the proposed trade name, and has not been approved by the FDA. For simplicity, this report refers to the product as Rexista. In Company Briefing Materials, Intellipharmaceutics also referred to the product as “IPC Oxy”.