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POZEN announced the start of enrollment for the phase 3 studies for PA32540
CHAPEL HILL, NC, USA | November 20, 2009 | POZEN Inc. (NASDAQ: POZN) announced today 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.
About POZEN
POZEN Inc., headquartered in Chapel Hill, NC, is a pharmaceutical company committed to transforming medicine that transforms lives. Since its founding in 1996, POZEN has successfully created novel pharmacologic agents primarily for pain and pain-related conditions by combining existing drug therapies that result in superior patient outcomes. Moving forward, POZEN is poised to become a model 21st Century pharmaceutical company dedicated to ensuring that they produce cost-effective, evidence-based medicines; take a fresh approach to sales, marketing and medical education; and deliver high-quality, affordable pharmaceuticals to our customers. The company’s common stock is traded on The NASDAQ Stock Market under the symbol “POZN”. For more detailed company information, including copies of this and other press releases, please visit: www.POZEN.com.
SOURCE: POZEN Inc. |
