POZEN Announces Start Of Enrollment For PA32540 Phase 3 Program

Main Category: Heart Disease
Also Included In: Clinical Trials / Drug Trials;  Stroke
Article Date: 23 Nov 2009 - 4:00 PST

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POZEN Inc. (NASDAQ: POZN) announced the start of enrollment for the phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole, under investigation for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers.

"We believe that PA32540 could address the needs of certain patients with cardiovascular disease," said John Fort, MD, Chief Medical Officer, POZEN. "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."

About the Studies

POZEN is conducting two pivotal phase 3 studies and one long-term safety study. The two Phase 3 pivotal trials will be conducted under a Special Protocol Assessment agreed with the Food and Drug Administration. These 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 325 mg of enteric-coated aspirin.

The long-term safety study will be enrolling approximately 400 subjects and will assess the safety of PA32540 over one year.

Source
POZEN