ARTICLE | Clinical News

Panel rejects Intellipharmaceutics' Rexista abuse deterrence claims

July 28, 2017 7:59 PM UTC

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety & Risk Management Advisory Committees voted 22-1 against approval of Rexista oxycodone XR from Intellipharmaceutics International Inc. (TSX:IPCI; NASDAQ:IPCI), and voted 23-0 that available data were insufficient to support claims of abuse deterrence on its label.

FDA is reviewing an NDA for Rexista to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Rexista’s PDUFA date is Sept. 25...