Pozen posts positive PN 400 results
Patients taking Pozen's PN 400 have statistically significantly fewer endoscopically confirmed gastric ulcers than those taking enteric-coated naproxen in a six-month Phase III trial, the firm says Dec. 3. PN 400, a fixed-dose combination of the NSAID naproxen (500 mg) and proton pump inhibitor esomeprazole (20 mg), is being developed under a Special Protocol Assessment with FDA. However, FDA is re-evaluating the use of endoscopy to detect reduction of gastric ulcers as an endpoint and plans a meeting in first quarter 2009 to discuss the issue (1"The Pink Sheet," Nov. 17, 2008, p. 31). Pozen is partnered with AstraZeneca in development of the drug
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