Complete response for QRxPharma's MoxDuo IR
FDA issued a complete response letter to an NDA from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) for MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. The company submitted a revised analysis of the Phase III Study 022 results last month and had previously said it expected FDA to delay the PDUFA date for the immediate-release combination of oxycodone and morphine. The revision corrected an error in the time points at which some respiratory data in the trial were collected (see BioCentury Extra, July 12).
According to QRxPharma, FDA issued the complete response letter to allow the company "time to submit and evaluate further information" required for the agency to "fully consider the respiratory safety advantages" of MoxDuo in Study 022. QRxPharma plans to resubmit the NDA next quarter. ...