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POZEN Inc Announces FDA Acceptance Of Filing Of New Drug Application For PA32540/PA8140 Tablets


Wednesday, 29 May 2013 07:30am EDT 

POZEN Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for review, the New Drug Application (NDA) for PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. The FDA also indicated the review classification is Standard; therefore, the user fee goal date is January 24, 2014. Pending FDA review and approval, an indication is sought for PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. The NDA submission is based on data from a comprehensive clinical trials program that POZEN conducted. This program included two pivotal Phase 3 studies (PA32540 - 301/PA32540 - 302) for PA32540, conducted under special protocol assessment (SPA) agreed with the FDA, which met their primary and secondary endpoints, as well as Phase 1 studies for both PA32540 and PA8140. In the 301 and 302 studies, significantly fewer subjects taking PA32540 experienced endoscopically confirmed gastric ulcers compared to subjects receiving enteric-coated (EC) aspirin alone (Study 301: 3.8% vs. 8.7%, p=0.02; Study 302: 2.7% vs. 8.5%, p=0.005, respectively). 

Company Quote

7.92
-0.25 -3.06%
22 Dec 2014