Edited Press Release
LONDON -(Dow Jones)- AstraZeneca and POZEN, co-development partner for the investigational compound PN 400, said Wednesday that 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, 400 subjects received either PN 400 or enteric-coated naproxen 500 mg, twice daily, over a six-month treatment period, it said.
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, it said.
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.
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.
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(END) Dow Jones Newswires
December 03, 2008 08:24 ET (13:24 GMT)

Publié le 03 Décembre 2008 Copyright © 2008 Dowjones