POZEN Inc. (POZN),a pharmaceutical company, reported submitting a New Drug Application or NDA for the marketing approval of PA32540/PA8140 to the U.S. Food and Drug Administration or FDA. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor or PPI, layered around a pH-sensitive coating of an aspirin core. Pending regulatory approval, an indication is sought for the use of PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
John Plachetka, Pharm.D., Chairman, President and Chief Executive of POZEN noted, "Although this PA NDA is focused on patients who need the beneficial lifesaving cardiovascular properties of aspirin but are at risk for developing gastric ulcers, it is our hope that sometime in the future additional research will confirm the promise of aspirin as an important drug in the war against cancer, and perhaps other diseases. In discussions with potential partners, we believe we have seen the same commitment from them to transform the benefit/risk profile of aspirin that has driven our team at POZEN over the past several years."
The NDA submission is based on data from a comprehensive studies program that POZEN conducted. This program included two pivotal Phase 3 trials for PA32540, conducted under special protocol assessment or SPA agreed with the FDA, which met their primary and secondary endpoints, as well as extensive Phase 1 studies for both PA32540 and PA8140.
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