POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today positive top-line results from two pivotal Phase 3 clinical trials of PA32540, a novel, coordinated-delivery tablet of immediate-release omeprazole (40 mg) and delayed release aspirin (325 mg).
The two Phase 3 pivotal trials were randomized, double-blind, multi-center studies in which a total of 1,049 subjects at risk for developing aspirin-associated ulcers and already taking aspirin at a dose of 325 mg once daily for at least three months for secondary prevention of cardiovascular events were randomly assigned to treatment with either PA32540 or 325 mg 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. Additionally, the studies met their key secondary endpoints, including a reduction in gastroduodenal ulceration as well as a reduction in discontinuation due to upper gastrointestinal adverse events in subjects taking PA32540 compared to 325 mg enteric-coated aspirin. Reported adverse events were consistent with the trial population and the known adverse event profile of aspirin and omeprazole. Further analyses of the data will be conducted, and presentation of the data at an appropriate upcoming scientific meeting, as well as publication of the full results, is planned.
“We are encouraged by the strength of the data and I commend the clinical team here at POZEN and all our associates for their dedication and hard work,” said John R. Plachetka, Pharm.D., the Company’s Chairman, President and Chief Executive Officer. “This information is essential to progress our PA32540 partnership discussions for the United States, and to allow us to continue to move forward with our preparations for a third quarter NDA submission for this product candidate.”
About PAPOZEN is creating a portfolio of integrated aspirin therapies - the PA product platform. The products in the PA portfolio are intended to significantly reduce GI ulcers and other GI complications compared to taking aspirin alone.