ARTICLE | Company News

Advisory committee rebuffs MoxDuo IR

April 23, 2014 12:03 AM UTC

FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 14-0 against approval of MoxDuo IR morphine/oxycodone from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) to treat moderate to severe acute pain. The panel also voted unanimously that the company did not provide evidence that MoxDuo IR is safer than its individual components at comparable doses. MoxDuo IR, an immediate-release combination of oxycodone and morphine, has a May 25 PDUFA date (see BioCentury Extra, April 18). ...