Pozen, a Chapel Hill, N.C.-based pharmaceutical company, released positive top-line results from two pivotal phase III clinical trials of PA32540, a novel, coordinated-delivery tablet of immediate-release omeprazole (40mg) and delayed release aspirin (325 mg).
The two trials were randomized, double-blind, multi-center studies in which 1,049 subjects at risk for developing aspirin-associated ulcers and already taking aspirin at a dose of 325mg once daily for at least three months for secondary prevention of cardiovascular events 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. 325mg 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 and a reduction in discontinuation due to upper gastrointestinal adverse events in subjects taking PA32540 compared to 325mg 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.