QRxPharma Limited announced that the company resubmitted its MOXDUO(R) New Drug Application (NDA). As disclosed on 16 January 2013, at its last meeting with the Company, the US Food and Drug Administration (FDA) requested the resubmission of the NDA to include the respiratory safety results of Study 022. QRxPharma believes the resubmitted clinical data demonstrate safety advantages of MOXDUO over its components, morphine and oxycodone, and that MOXDUO provides as good or better analgesia as indicated by past studies involving more than 1,600 patients experiencing moderate to severe acute post-operative pain. The primary safety advantage of MOXDUO over its components is a reduction in respiratory risks evident in the data from Study 022. Furthermore, cross study analyses of all patients in the NDA programme demonstrate that MOXDUO is associated with less vomiting and a lower incidence of other side effects than comparable analgesic doses of morphine or oxycodone. MOXDUO also provides a safer starting dose and finer dose titration steps than either of its components, thus giving greater flexibility to physicians and patients as the need for pain relief is balanced with the lower risks of side effects. The FDA confirmed that there were no efficacy or safety issues in any of the studies that were part of the original NDA. The resubmitted application, including new results from Study 022, will undergo review by an Advisory Committee to evaluate the approvability of MOXDUO in the management of acute pain. By the end of this quarter, the Company expects to be notified of the new Prescription Drug User Fee Act (PDUFA) date for action by the FDA, as well as the date for the Advisory Committee meeting.

QRxPharma Limited reported consolidated earnings results for the half year ended December 31, 2012. For the period, the company's revenue from continuing operations was AUD 2.24 million compared to AUD 0.356 million a year ago. Loss before income tax was AUD 5.21 million compared to AUD 5.67 million a year ago. Loss from continuing operations was AUD 5.21 million compared to AUD 5.67 million a year ago. Loss was AUD 5.21 million compared to AUD 5.67 million a year ago. Loss attributable to owners of the company was AUD 5.21 million or 3.6 cents per basic and diluted share compared to AUD 5.65 million or 4.0 cents per basic and diluted share a year ago. Net cash outflow from operating activities was AUD 6.04 million compared to AUD 1.92 million a year ago. Payments for property, plant and equipment was AUD 9,000 compared to AUD 49,000 a year ago.

QRxPharma Limited announced that they will report first half, 2013 results on Feb 18, 2013