POZEN has reported positive top-line results from two pivotal Phase 3 clinical trials of PA32540, indicated for the secondary prevention of cardiovascular disease in patients at risk of aspirin-induced ulcers.
PA32540 is a coordinated-delivery tablet combining immediate-release omeprazole, a proton pump inhibitor, layered around pH-sensitive aspirin.
The two Phase 3 pivotal trials were randomised double-blind multi-centre studies in which a total of 1,049 subjects at risk of developing aspirin-associated ulcers were randomly assigned to treatment with either PA32540 or 325mg enteric-coated aspirin once daily.
The studies met the primary endpoint, including a considerable reduction in the cumulative incidence of gastric ulcers following administration of PA32540 versus 325mg enteric-coated aspirin over six months.
The trials also met 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.
Pozen president and chief executive officer John Plachetka said: "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."
Pozen is a progressive pharmaceutical company that is now creating a portfolio of cost-effective, evidence-based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.
The company has already completed the long-term safety study and the two pivotal studies, targeting a New Drug Application submission for Q3 2012.