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POZEN’s phase I Co-Rx study shows positive results

Monday, November 14, 2011

POZEN, a pharmaceutical company, has reported positive results from a phase I 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]). These findings are directly relevant to the treatment of patients with gastrointestinal (GI) risk who require dual antiplatelet therapy (DAPT) and gastroprotection.

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.

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