POZEN has reported positive results from Phase 1 study of PA8140, a combination of aspirin (81mg) and omeprazole (40mg).
The study demonstrated comparable bioavailability relative to enteric-coated (EC) aspirin (81mg), the reference listed product for gastric ulcers.
The study also found that, considering highly variable drug criteria, PA8140 is bioequivalent to EC aspirin (81mg).
Pozen chief medical officer Dr. John Fort said the adjustments made in the trial design on the basis of earlier studies with PA formulations and discussions, improved the ability to capture and measure blood levels of aspirin.
"We believe that these results will satisfy the requirements set forth by the Food and Drug Administation (FDA) for establishing a therapeutic bridge to EC aspirin (81 mg) for this lower strength of PA tablets," Dr. Fort added.
PA is a portfolio of integrated aspirin therapies that are targeted toward mitigating GI ulcers and other GI complications.
The portfolio includes PA32540, which contains 325mg of aspirin, and PA8140with 81mg of aspirin.
All the trials will be included in the PA32540/PA8140 new drug application (NDA).
The company also completed manufacturing PA8140 tablet batches that met all predetermined specifications, essential for primary NDA stability programme.
Pozen chief commercial officer and executive vice president Liz Cermak said: "If approved, the availability of both 81 mg and 325 mg doses of PA will allow us to provide physicians an option for virtually all of their secondary prevention cardiovascular patients who are at risk for gastric ulcers, dramatically improving the commercial opportunity for PA."