POZEN announces positive results from two Phase III ulcer studies
POZEN Inc., a pharmaceutical company, has announced 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 325mg.
The two Phase III 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.
The first candidate is PA32540. It is a coordinated-delivery tablet combining immediate-release omeprazole, a proton pump inhibitor, layered around pH-sensitive aspirin. This novel, patented product is administered orally once a day and will be indicated for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers. POZEN has completed the long-term safety study and the two pivotal studies, targeting a New Drug Application submission for 3Q12.
"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 CEO. "This information is essential to progress our PA32540 partnership discussions for the US, and to allow us to continue to move forward with our preparations for a third quarter NDA submission for this product candidate."
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Published: Mar 26, 2012 (Datamonitor via COMTEX) --
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