FDA decision on MoxDuo expected mid-2013

After being cleared to submit existing trial data to back up its IND application for pain formulation MoxDuo IR, QRxPharma (ASX:QRX) now expects the US FDA to make its decision in mid-2013.

The FDA had knocked back QRxPharma's initial application in June, requesting additional safety and efficacy data.

This raised the prospect of a long delay to the approvals process for QRxPharma and marketing partner Actavis, if an additional clinical trial was required.

But at a meeting with the FDA last month, QRxPharma was cleared to submit additional analysis of existing trial data.

QRxPharma today updated its investor presentation materials filed with the ASX to show that it expects to file the additional data package required by the agency in the second half of this year. The company then expects a decision on the refiled New Drug Application in mid-2013.

Prior to the knock-back, the PDUFA date – the target date for the FDA's decision – had been June 25 this year.

The presentation also shows that QRxPharma and Actavis plan to submit additional regulatory filings in Europe, Australia and Canada in 1H13, and that they are targeting peak sales for the drug of $680 million per year.

MoxDuo IR is the immediate release version of MoxDuo, QRxPharma's proprietary 3:2 combination of morphine and oxycodone.

The controlled release variant, MoxDuo CR, is heading for the phase II trial stage. This product has the potential to be even more profitable, the presentation shows, with QRxPharma targeting peak net sales of $1.3 billion.

QRxPharma (ASX:QRX) shares were trading unchanged at $0.685 as of around 3:30pm on Thursday.