ASTRAZENECA AND POZEN INFORMED OF FDA INTERNAL REVIEW OF GASTRIC ULCERS AS A PRIMARY ENDPOINT IN TRIALS
AstraZeneca and POZEN Inc., co-development partner for the investigational compound PN 400, have announced today that the U.S. Food and Drug Administration (FDA) has informed POZEN that it is conducting an internal review on the acceptability of endoscopic gastric ulcers as a primary endpoint in clinical studies. The FDA has not indicated when their internal review will be completed, although an FDA internal meeting has been scheduled to review this subject during the first quarter of 2009.
At the completion of the Special Protocol Assessment (SPA) for the PN 200 compound, POZEN had reached an agreement with the FDA on the design of its pivotal trials for PN 200 (omeprazole 20 mg and naproxen 500 mg), which specified the primary endpoint as the reduction in gastric ulcers versus enteric coated naproxen. The FDA confirmed that the development programme for PN 200 also applied to PN 400.
It is unclear at this time what impact, if any, the FDA’s internal review will have. However, the PN 400 clinical programme will continue to progress under the SPA agreed development plan with the FDA.
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17 October 2008
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About PN 400:
PN 400 is an investigational compound under co-development by AstraZeneca and POZEN, Inc. that combines the pain reliever naproxen (a non-steroidal anti-inflammatory drug, or 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.
About AstraZeneca
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