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news.Pozen has seen its share price rise having presented study data for Trexima, which showed that the migraine treatment achieved statistical significance for all regulatory endpoints in a pivotal clinical trial.
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Trexima, developed in collaboration with GlaxoSmithKline, is the proposed brand name for the single tablet that combines sumatriptan and naproxen.
The drug demonstrated superiority over its individual components on delivering a pain-free response to participants whilst meeting all regulatory endpoints. Compared to placebo it also produced significant results with respect to pain and associated symptoms of nausea, photophobia, and phonophobia.
Having met with the FDA to discuss trial results, Prozen believes that no additional preclinical or clinical trials are necessary before submission of an official application. “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 Plachetka, chairman, president and CEO.