POZEN presents PA32540 Phase 1 study results for cardiovascular disease at AHA Session

Nov 15 2010

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today the results of a Phase 1 study, which reported that PA32540, a novel coordinated-delivery tablet of enteric-coated aspirin (325 mg) and immediate-release omeprazole (40 mg), showed no ex vivo drug-drug interaction with clopidogrel when administered 10 hours apart in healthy patients, based on the study's pre-specified analysis. The results from this investigation were presented today, Sunday, November 14, 2010, at the American Heart Association (AHA) Scientific Sessions in Chicago, Illinois (Poster Board 6004, Abstract #3120).

“Further investigation of PA32540 is warranted for patients who require dual antiplatelet therapy but are at risk for a gastric ulcers and bleeding.”

"The results of the SPACING study provide important insights into the interaction between immediate-release omeprazole and clopidogrel," said Paul Gurbel, M.D., Director of Cardiovascular Research at the Center for Thrombosis Research at Sinai Hospital of Baltimore, and lead investigator for the study. "Further investigation of PA32540 is warranted for patients who require dual antiplatelet therapy but are at risk for a gastric ulcers and bleeding."

PA32540, an investigational coordinated-delivery tablet of immediate-release omeprazole, a 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 portfolio of integrated aspirin therapies, called the PA product platform.

"This Phase 1 study may further support the promise of PA32540. The immediate-release omeprazole contained in PA32540 may offer a different clopidogrel-antiplatelet interaction profile for PA32540 as compared to enteric coated PPIs and clopidogrel," said John G. Fort, M.D., Chief Medical Officer of POZEN and co-investigator for the study. "At POZEN, we are looking forward to further investigating the potential of PA32540 for patients who may benefit from aspirin therapy but are at risk for gastric ulcers."