Pozen has initiated the enrollment for the Phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325mg of enteric coated aspirin and 40mg of immediate release omeprazole.
PA32540, is under investigation for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers.
The company is conducting two pivotal Phase 3 studies and one long-term safety study. The two Phase 3 pivotal trials is expected to be conducted under a Special Protocol Assessment agreed with the FDA.
Reportedly, studies will involve over 100 sites, enrolling approximately 500 patients per study. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325mg of enteric-coated aspirin.
The company said that the long-term safety study will be enrolling approximately 400 subjects and will assess the safety of PA32540 over one year.
John Fort, chief medical officer at Pozen, said: “We believe that PA32540 could address the needs of certain patients with cardiovascular disease. We look forward to progressing the development of PA32540 through Phase 3 studies, enabling us to bring this potentially important advancement to those who need it.”