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Sumatriptan-Naproxen Combo Reaches Endpoint in Second Phase 3 Trial
POZEN also announced that it has met with the FDA and discussed the results of both Phase III trials and other information required for the submission of the Trexima NDA. Based upon discussions at the pre-NDA meeting, POZEN believes that no additional pre-clinical or clinical trials are necessary for submission. The Trexima NDA submission is now scheduled for the third quarter of 2005.
In the second Phase III study, Trexima demonstrated superiority over the individual components on the primary endpoint and also met all the regulatory endpoints for a new migraine product. For the combination, Trexima demonstrated a superior sustained pain-free response versus naproxen (p "We are obviously very pleased with the pre-NDA meeting resulting in our ability to submit the Trexima NDA early in the second half of this year," said Dr. John R. Plachetka, Chairman, President and CEO. "The team has done a remarkable job in completing the two pivotal studies in less than a year from start to finish."
Source: Pozen and GlaxoSmithKline