Pozen Submits Final Study Report For PA8140/PA32540 Phase 1 Study

(RTTNews) - Pozen Inc. (POZN) said Wednesday that it has submitted the final study report for the Phase 1 study comparing the pharmacokinetic profile of the omeprazole component of PA8140 tablets to that of PA32540 tablets as agreed with the U.S. Food and Drug Administration.

PA8140/PA32540 Tablets contain 81 mg or 325 mg delayed release aspirin and 40 mg immediate-release omeprazole and are indicated for patients who require aspirin to reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris, to reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris, in patients who have undergone revascularization procedures (CABG, PTCA) when there is a pre-existing condition for which aspirin is already indicated, and to decrease the risk of developing gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers.

Controlled studies with PA8140/PA32540 Tablets do not extend beyond 6 months.