FDA to again review QRxPharma's MoxDuo IR

FDA accepted for review a resubmitted NDA from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) for MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. The PDUFA date is May 25. The company said FDA will schedule an advisory committee meeting to discuss the NDA, which contains an audit of data from the company's Phase III Study 022 trial. In August, FDA issued a complete response letter for the product after QRxPharma submitted a revised analysis following discovery of an error in the time points at which some respiratory data in Study 022 were collected. MoxDuo IR is an immediate-release combination of oxycodone and morphine (see BioCentury Extra, Aug. 28). ...