MoxDuo IR morphine/oxycodone regulatory update

QRxPharma said it will resubmit an NDA this quarter for MoxDuo IR (12 mg morphine/8 mg oxycodone) to manage acute pain following clarification with FDA on the necessary steps for approval. The company expects a new PDUFA date to be set in 3Q13, with a launch the same quarter. QRxPharma received a complete response letter from FDA for MoxDuo IR last June requesting 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 (see BioCentury, July 2, 2012).

In a meeting last August, FDA requested further information regarding data and additional analysis of completed trials, including the completed Phase III Study 022 trial, in which MoxDuo IR led to significantly less respiratory depression as measured by oxygen desaturations, the primary endpoint, vs. 16 mg oxycodone alone for up to 2 days. MoxDuo IR also showed "beneficial trends" on the endpoint compared to 24 mg morphine alone (see BioCentury, July 25, 2011). At the August meeting, QRxPharma also said FDA confirmed the Phase III Study 008 trial of MoxDuo IR satisfied efficacy requirements and there were no unexpected or problematic safety issues in any of the studies submitted as part of the NDA. ...