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news.POZEN has reported positive top-line results from two pivotal Phase III trials of PA32540, a coordinated-delivery tablet of immediate-release omeprazole (40mg) and delayed release aspirin (325mg).
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The randomized, double-blind, multi-center studies were randomly assigned to treatment with either PA32540 or 325mg enteric-coated aspirin once daily.
The primary endpoint, a significant reduction in the cumulative incidence of gastric ulcers following administration of PA32540 vs. 325 mg enteric-coated aspirin over six months, was met in both studies.
The studies also met their key secondary endpoints, the company said.
The secondary endpoints include a reduction in gastroduodenal ulceration as well as a reduction in discontinuation due to upper gastrointestinal adverse events in subjects taking PA32540 compared to 325mg enteric-coated aspirin.
POZEN chairman, president and chief executive officer John Plachetka said the information will allow the company to continue to move forward with the preparations for a third quarter NDA submission for this product candidate.