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Company Announces Filing of Special Protocol Assessment for PA32540
CHAPEL HILL, NC, USA | June 9, 2008 | POZEN Inc. (NASDAQ:POZN), today announced that is has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for its pivotal Phase 3 trials for PA32540. The company had previously met with the FDA to discuss the overall development program requirements.
As part of the SPA submission, the company has provided data indicating that PA32540 is bioequivalent to 325mg enteric coated aspirin. By demonstrating bioequivalence to enteric coated aspirin, we believe PA32540, if approved, will receive all of aspirin's claims for the secondary prevention of cardiovascular events, such as heart attacks and strokes.
Dr. Marshall E. Reese, executive vice president, product development stated, "All aspects of the PA program are on target, and we expect to be in a position to begin the Phase 3 trials after we finalize the SPA with the FDA, which we anticipate will be during the third quarter of 2008."
PA32540, a patented investigational product containing aspirin 325mg and omeprazole 40mg in a unique dosage form, is designed to deliver the cardiovascular benefits of aspirin with a lower incidence of gastric ulcers than enteric coated aspirin.
About Cardiovascular Disease and Stroke
Nearly 2,400 Americans die of cardiovascular disease each day--an average of one death every 37 seconds. In 2008, an estimated 770,000 Americans will have a new coronary attack, and about 430,000 will have a recurrent attack.
Each year, about 780,000 people experience a new or recurrent stroke.
About POZEN
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN's efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for Treximet(TM), which was recently approved by the United States Food and Drug Administration for the acute treatment of migraine attacks; and with AstraZeneca for proprietary fixed dose combinations of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: www.pozen.com.
SOURCE: POZEN Inc. |
