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QRxPharma Receives Positive Feedback from Scientific Advice Meetings in Europe on MoxDuo®IR Development and Registration
Date:7/26/2010

S 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 n=300). This study will include the proposed primary safety endpoints of the occurrence rate of moderate-severe nausea, emesis or dizziness, with an improvement for MoxDuo IR compared to morphine and oxycodone treatments being defined as a clinically relevant effect.

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.

About Scientific Advice:

The Scientific Advice process provides QRxPharma a forum to discuss the adequacy of its MoxDuo IR development plan as well as the results obtained to date for product registration purposes. The responses given by the Agencies are based on the questions and documentation submitted for discussion and cannot account for future changes or developments in scientific knowledge or regulatory requirements. Scientific Advice given i
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