Published on September 6, 2013 at 11:24 AM
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the United States Food and Drug Administration (FDA) has scheduled a meeting on 3 October to discuss the Company's MOXDUO New Drug Application (NDA) for the treatment of moderate to severe acute pain. The meeting was granted by the FDA after issuance of a Complete Response Letter (CRL) last month, and will focus on outstanding issues that need to be addressed in the revised NDA and data validation documentation.
The Company is nearing completion of its full audit of the over 30 million data points for oxygen saturation from Study 022 to ensure data integrity. Subject to advice from the FDA on 3 October, we shall refile our NDA incorporating this analysis as soon as possible after the meeting. At this stage we anticipate a new PDUFA (Prescription Drug User Fee Act) date in Q2 2014, preceded by an Advisory Committee meeting.
"We are encouraged by the prompt response by the FDA to engage in a face-to-face review of the remaining issues to be resolved prior to our resubmission of the NDA and accompanying data analyses," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "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."
The revised NDA is the basis for recommencing the regulatory approval process for MOXDUO for the treatment of moderate to severe acute pain, a $2.5 billion USD segment of the $8 billion USD spent annually on prescription opioids in the United States. The Company believes that MOXDUO is on track to launch in the United States in 2014.
SOURCE QRxPharma Limited