Complete response for MoxDuo IR

FDA issued a complete response letter to QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) for MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. The company said the agency requested clinical data showing "a clear benefit over oxycodone and morphine alone, either by efficacy, or safety, in an appropriate patient population." The company plans to request a meeting with FDA to clarify. MoxDuo IR is an immediate-release combination of oxycodone and morphine.

In April, FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 14-0 against approval of MoxDuo IR, noting the company did not provide evidence that it was safer than its individual components at comparable doses. ...