PN 400 Phase III Studies Show Clinically Meaningful Benefit in Reducing Gastric Ulcers Compared to Enteric-Coated Naproxen
LONDON, Dec. 3, 2008-AstraZeneca and POZEN Inc., co-development partner for the investigational compound PN 400, have announced today results from two Phase III studies, PN 400-301 and PN 400-302 comparing PN 400 (enteric-coated naproxen 500 mg and immediate release esomeprazole 20 mg) to enteric-coated naproxen 500 mg. These studies were conducted by POZEN under an agreed Special Protocol Assessment (SPA) with the FDA.
The PN 400-301 and PN 400-302 studies both achieved the primary endpoints. Subjects taking PN 400 experienced statistically significantly fewer endoscopically confirmed gastric ulcers than those taking naproxen. In each of the trials, approximately 400 subjects received either PN 400 or enteric-coated naproxen 500 mg, twice daily, over a six-month treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months. The primary endpoint was the cumulative incidence of gastric ulcers. Full results of the PN 400-301 and PN-400 302 will be published in a timely manner.
The Food and Drug Administration (FDA) has recently informed POZEN that they are conducting an internal review on the acceptability of using endoscopic gastric ulcers as a primary endpoint in clinical studies. The FDA has not indicated when their internal review will be completed, although the FDA has scheduled an FDA internal meeting to review this subject during the first quarter of 2009.
Two additional Phase III studies, PN-400-307 and PN 400-309, are still ongoing. Upon completion of the entire PN 400 Phase III clinical programme, AstraZeneca will make a final determination regarding regulatory filing, which is planned for mid-2009.
3 December 2008
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Notes To Editors
About PN 400
PN 400 is an investigational compound under co-development by AstraZeneca and POZEN, Inc. that combines the pain reliever naproxen (an NSAID) with esomeprazole – a proton pump inhibitor (PPI), for the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of developing gastric ulcers.
Osteoarthritis is one of the most frequent causes of physical disability among adults; with an estimated 46 million adults in the US have physician-diagnosed arthritis, accounting for 21 percent of the US adult population. Two thirds of the people that have doctor-diagnosed arthritis are under the age of 65.
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more Information visit www.astrazeneca.com
Posted: December 2008