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Pozen/AZ Combo Pill Could See Setback As FDA Reviews Trial Endpoints

This article was originally published in The Pink Sheet Daily

Executive Summary

Phase III studies of the NSAID/PPI combination are set to wrap up, but agency now is reviewing use of endoscopic gastric ulcers as an endpoint.

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Pozen wins at FDA’s regulatory briefing

FDA finds endoscopic gastric ulcer incidence to be an acceptable primary endpoint for Pozen's combination naproxen/esomeprazole product, PN 400. FDA had undertaken a review of the clinical trial design that could have forced Pozen to redo its clinical trials; an NDA submission is now planned for 2009 (1"The Pink Sheet" DAILY, Oct. 17, 2008). The issue of whether to accept the gastric ulcer endpoint was to be the subject of an FDA regulatory briefing earlier this year (2The RPM Report, November 2008). FDA is continuing to review possible changes to clinical trial requirements for combination NSAID/proton pump inhibitors (3"The Pink Sheet," Nov. 17, 2008, p. 31)

Pozen wins at FDA’s regulatory briefing

FDA finds endoscopic gastric ulcer incidence to be an acceptable primary endpoint for Pozen's combination naproxen/esomeprazole product, PN 400. FDA had undertaken a review of the clinical trial design that could have forced Pozen to redo its clinical trials; an NDA submission is now planned for 2009 (1"The Pink Sheet" DAILY, Oct. 17, 2008). The issue of whether to accept the gastric ulcer endpoint was to be the subject of an FDA regulatory briefing earlier this year (2The RPM Report, November 2008). FDA is continuing to review possible changes to clinical trial requirements for combination NSAID/proton pump inhibitors (3"The Pink Sheet," Nov. 17, 2008, p. 31)

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