QRxPharma reports positive outcome of European Scientific Advice meetings on MoxDuo IR pain therapy

Jul 26 2010

QRxPharma (ASX: QRX and Pink Sheets: QRXPY) reported today positive outcomes of its European Scientific Advice meetings on the development and registration of MoxDuo IR, an immediate release Dual-Opioid™ pain therapy. The Company is currently completing pivotal Phase 3 trials required for filing a New Drug Application (NDA) for MoxDuo IR with the United States Food and Drug Administration (FDA). QRxPharma intends to submit a Marketing Authorisation Application (MAA) in Europe, the second largest market (approximately US$3.5 billion) in the world for opioid analgesics. In support of these registration activities, the Company held Scientific Advice meetings in Germany and the United Kingdom in May 2010. Based on the positive responses in the official minutes of these meetings, QRxPharma intends to select Germany as the lead Agency for European MAA review, and will submit the application in 2011.

"Similar to the FDA's acceptance of our streamlined development plan for MoxDuo IR, feedback and guidance from the European Agencies regarding the suitability of our data package for MAA submission is also positive," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "Our objective is to launch MoxDuo IR globally in 2012, and this feedback clears a significant hurdle and facilitates our European regulatory and commercialisation strategy."

In reply to questions posed by QRxPharma to the German Federal Institute for Drugs and Medical Devices (BfArM), the data package available from the US studies was considered acceptable for MAA submission in Europe with the addition of a Phase 3 study in bunionectomy patients comparing the adverse event profile of MoxDuo IR to equianalgesic doses of morphine and of oxycodone (total>

Assuming a positive outcome of this additional study and pending review of the MAA, such differences may be cited in the product package labelling in Europe and will further augment data for label claim submission with the FDA in the US.

QRxPharma successfully completed a pivotal Phase 3 "combination rule" study in April 2010 and announced that primary and secondary endpoints were achieved. In this study, MoxDuo IR 2 demonstrated both a statistically superior analgesic effect compared to morphine and oxycodone alone as well as a favourable side effect profile despite delivering twice the opioid dose of its individual components. These findings complement earlier clinical trials demonstrating that MoxDuo IR opens the therapeutic window by providing significant acute pain relief while reducing side effects.

SOURCE QRXPharma