Combination of POZEN’s PA32540 and clopidogrel results in greater antiplatelet effects

Aug 30 2012

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced the presentation of Phase 1 data, at the European Society of Cardiologists 2012 Congress, from a study of PA32540, a novel coordinated-delivery tablet of enteric-coated (EC) aspirin (325 mg) and immediate-release (IR) omeprazole (40 mg). The data from the Co-Rx Study (pronounced "Co-Rex") suggest that PA32540 given in conjunction with clopidogrel, dosed at least 10 hours apart, resulted in greater antiplatelet effects than synchronously administered EC aspirin (81 mg), clopidogrel (75 mg), and EC omeprazole (46.5% versus 39.9%, respectively, at day 7: 95% confidence interval of the difference [2.57, 11.91]; p=0.004], in healthy volunteers. These data were further presented at the European Society of Cardiologists 2012 Congress in Munich, Germany on August 26, 2012.

"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 aspirin-associated gastric ulcers. This investigational product is part of POZEN's pipeline of integrated aspirin therapies, called the PA product portfolio.

Separately, POZEN is pleased to announce the acceptance of abstracts with regard to its clinical program for PA32540 at both the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting, as well as at The American Heart Association (AHA) 2012 Scientific Sessions.

Additionally, POZEN provided an update on its PA program and the results of its Type A meeting with the FDA last week, wherein the Company indicated that it is currently anticipating an NDA submission in the first half of 2013.