QRxPharma, FDA to discuss MoxDuo setback in October

QRxPharma (ASX:QRX) has arranged to meet with the US FDA in October to discuss the latest regulatory knockback for dual-opioid pain treatment MoxDuo IR.

The FDA last month issued a second Complete Response Letter (CRL) requesting QRxPharma again resubmit its New Drug Application with more information and analysis.

The agency has now scheduled a meeting with QRxPharma on 3 October to discuss the CRL and the outstanding issues that need to be addressed.

The CRL had concentrated on data from one particular safety study on the respiratory safety advantages of MoxDuo compared to equally effective doses of morphine or oxycodone.

QRxPharma said it is nearing completion on the additional analysis expected to be required - a full audit of over 30 million data points for oxygen saturation. Subject to advice given by the FDA, the company plans to refile its NDA as soon as possible after the 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,” QRxPharma CEO Dr John Holaday said.

He said at this stage, the company anticipates a new PDUFA date - or deadline for the FDA’s decision on approval - of Q2 2014.

The FDA issued its first CRL to QRxPharma’s MoxDuo application in June 2012. The decision came as a surprise, given the history of therapeutic use of  morphine and oxycodone and the positive trial results supporting the application.

QRxPharma (ASX:QRX) shares were trading 0.69% higher at $0.73 as of around noon on Monday.