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POZEN Inc. (NASDAQ: POZN),
a pharmaceutical company committed to transforming medicine that transforms lives, presented data today from a Phase 1 study that found that the investigational compound, PA32540, provides faster protection compared with delayed-release, enteric-coated omeprazole (40 mg), as measured by mean time to gastric pH. These data were presented for the first time at Digestive Disease Week (DDW) 2012 in San Diego, California at the San Diego Convention Center on May 19,
2012, at 9:15 a.m. (PT).
“In this study, the mean time to a gastric pH of greater than 4.0 was faster with PA32540 than with 40 mg of delayed-release, enteric-coated omeprazole,” said Philip B. Miner, Jr., M.D., President and Medical Director of the Oklahoma Foundation for Digestive Research and co-author of the study. “In addition, the 24-hour pH control achieved with the immediate release form of omeprazole in PA32540 should be sufficient for control of gastric acidity in patients taking chronic aspirin therapy for secondary cardiovascular prevention.”
About Study 112
Study 112 is a Phase 1, single-center, open-label, randomized, two-way crossover study that examined 26 healthy male and female volunteers who were
H. pylori negative. The study rationale was to gain an understanding of the anti-secretory and gastrointestinal (GI) therapeutic effect of the immediate-release omeprazole in PA32540. Subjects received either PA32540 once daily for seven days or enteric-coated aspirin (325 mg) plus enteric-coated omeprazole (40 mg) administered concomitantly once daily for seven days. After at least a seven-day washout, subjects were crossed over to the alternate treatment. Gastric pH and pharmacokinetics were measured over 24 hours on day seven of each treatment period.
Mean time to first gastric pH >4 was significantly faster with PA32540 compared to the enteric-coated aspirin + enteric-coated omeprazole group (PA32540: 17 minutes; enteric-coated aspirin + enteric-coated omeprazole: 36 minutes; p=0.011).
The percent time gastric pH >4 was 50.6 percent for PA32540 and 57.6 percent for enteric-coated aspirin + enteric-coated omeprazole group (p=0.004).
The relative bioavailability of omeprazole following seven daily doses with PA32540 was 43 percent lower than that from enteric-coated omeprazole 40 mg.
“In patients who require aspirin therapy and are at risk for UGI events, PA32540 could provide a consistent and coordinated therapeutic approach to cardio protection and reduced risk of UGI injury,” said John G. Fort, M.D., Chief Medical Officer of POZEN and co-author of the study. “These Phase 1 study findings support the coordinated-release design of PA32540, with the omeprazole in the outer layer of the tablet released first followed by aspirin. The Phase 3 top-line results of PA32540 support the gastro protective effects of PA32540.”