PA 32540 (Pozen) effective against Gastric Ulcers in Phase III study

Top-line results from Study 303, a Phase III trial tracking the safety of PA 32540, from Pozen Inc.,, in patients at risk for aspirin-associated Gastric Ulcers, shows that adverse events were consistent with those expected in this population of patients requiring cardio-aspirin therapy and with the known safety profile of the drug's components. PA 32540 is a combination tablet of immediate-release omeprazole (40mg) and delayed release aspirin (325mg). About 1,049 subjects at risk for developing aspirin-associated ulcers and already taking aspirin at a dose of 325mg once-daily for at least three months for secondary prevention of cardiovascular events were randomly assigned to treatment with either PA32540 or 325 mg enteric-coated aspirin once-daily. The primary endpoint, a significant reduction in the cumulative incidence of Gastric Ulcers following administration of PA 32540 over six months, was met in both studies. Additionally, the studies met their key secondary endpoints, including a reduction in gastroduodenal ulceration as well as a reduction in discontinuation due to upper gastrointestinal adverse events. Further analyses of the data will be presented at an upcoming scientific meeting. The company expects to submit an New Drug Application in the third quarter of 2012.