POZEN reports positive Phase 1 study results comparing PA32540 to clopidogrel for CVDs

Nov 15 2011

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented positive results today from a Phase 1 study comparing a dose-timing strategy of PA32540 and clopidogrel spaced 10 hours apart as compared to synchronous administration of enteric-coated (EC) omeprazole (40 mg), enteric-coated aspirin (81 mg) and clopidogrel (300 mg loading/75 mg daily). In the Co-Rx study, PA32540, a novel combination of 325 mg of aspirin and 40 mg immediate-release (IR) omeprazole, when dosed 10 hours apart from clopidogrel, was associated with greater platelet inhibition than synchronous administration of aspirin, clopidogrel and delayed-release omeprazole (46.5% versus 39.3%, respectively, at day 7 (95% CI [2.57, 11.91]; p = 0.004). These findings are directly relevant to the treatment of patients with gastrointestinal (GI) risk who require dual antiplatelet therapy (DAPT) and gastroprotection. The data was presented at the American Heart Association's 2011 Scientific Sessions in Orlando, Florida.

"The results of the Co-Rx study provide important insights into the interaction between omeprazole and clopidogrel," said Paul Gurbel, M.D., Director of the Sinai Center for Thrombosis Research at Sinai Hospital of Baltimore, who is a lead investigator for the study and an international authority on the pharmacodynamic effects of clopidogrel stated that, "Although the clinical significance of these results is presently unknown, treatment with PA32540 may be a promising option for the secondary prevention of heart attacks and strokes in cardiovascular patients who require prolonged aspirin and clopidogrel therapy but are at risk for gastric ulcers and bleeding."

PA32540, an investigational coordinated-delivery tablet of immediate-release omeprazole, a proton pump inhibitor (PPI), layered around pH-sensitive aspirin, is being investigated for the secondary prevention of cardiovascular disease in patients at risk for developing aspirin-associated gastric ulcers. This investigational product is part of POZEN's pipeline of integrated aspirin therapies, called the PA portfolio, all of which are designed to deliver the benefits of aspirin therapy with a reduced incidence of gastrointestinal damage.