MoxDuo IR morphine/oxycodone regulatory update

QRxPharma said it received a complete response letter from FDA for an NDA for MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. The company said the agency requested clarity on the product's safety and effectiveness, but did not request additional trials. On a conference call to discuss the letter, QRxPharma said the agency requested information relating to the combination rule, which requires the company to show that MoxDuo IR was safer or more effective than comparable doses of morphine and oxycodone. The company said it scheduled a meeting with FDA for mid-August to clarify next steps. ...