POZEN announced results from two pivotal Phase 3 clinical trials of PA32540, a coordinated-delivery tablet of immediate-release omeprazole (40mg) and delayed release aspirin (325mg) for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
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 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 as well as a reduction in discontinuation due to upper gastrointestinal adverse events in subjects taking PA32540 compared to 325mg enteric-coated aspirin.
PA32540 combines immediate-release omeprazole, a proton pump inhibitor, layered around pH-sensitive aspirin.
For more information call (919) 913-1030 or visit www.pozen.com.