FDA cancels MoxDuo advisory committee meeting

As expected, FDA canceled a July 17 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss an NDA for MoxDuo IR morphine/oxycodone from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY). The immediate-release combination of oxycodone and morphine is under review to treat moderate to severe acute pain, with an Aug. 26 PDUFA date. FDA said it canceled the meeting because "new information was submitted."

Last month, QRxPharma said it expected FDA to delay the meeting and PDUFA date for MoxDuo IR because it planned to submit a revised analysis of Phase III results to correct an error in the time points at which some data were collected (see BioCentury Extra, June 26). ...