The US Food and Drug Administration (FDA) has scheduled a meeting on 03 October 2013 to discuss QRxPharma's Moxduo new drug application (NDA) for the treatment of moderate to severe acute pain.
The meeting is aimed at focusing on outstanding issues that need to be addressed in the revised NDA and data validation documentation.
FDA has scheduled the meeting following issuance of a complete response letter (CRL) in August 2013.
QRxPharma is currently nearing completion of its full audit of the more than 30 million data points for oxygen saturation from Study 022 to ensure data integrity.
Subject to advice from the FDA, the company would resubmit its NDA incorporating the analysis as soon as possible after the meeting.
The company also expects a new Prescription Drug User Fee Act (PDUFA) date in the second quarter of 2014, preceded by an Advisory Committee meeting.
QRxPharma managing director and chief executive officer John Holaday said the company will also be engaged in a face-to-face review of the remaining issues to be resolved prior to its resubmission of the NDA and accompanying data analyses.
"After the meeting, we hope to have a clear agreement on next steps that will guide us in continuing the regulatory process to achieve MOXDUO approval,"