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FDA panel to review Intellipharmaceutics' analgesic

July 3, 2017 7:41 PM UTC

Intellipharmaceutics International Inc. (TSX:IPCI; NASDAQ:IPCI) said FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Advisory Committees are to meet July 26 to review an NDA for the company's Rexista oxycodone XR to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The therapy is a controlled-release formulation of oral oxycodone.

The company is seeking to include claims of abuse deterrence on the candidate's label. Rexista has Fast Track designation in the indication. Its PDUFA date is Sept. 25...