MoxDuo IR morphine/oxycodone regulatory update

FDA issued a complete response letter to QRxPharma 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 steps required for approval. MoxDuo IR is an immediate-release combination of oxycodone and morphine. ...