Advisory committee votes on ulcer endpoints

FDA's Gastrointestinal Drugs Advisory Committee voted 8-4, with one abstention, that endoscopically diagnosed gastric ulcers are an acceptable primary endpoint in trials evaluating misoprostol, histamine H2 receptor ( HRH2; H2R) antagonists and proton pump inhibitors (PPIs) to prevent NSAID-associated upper gastrointestinal toxicity. However, the committee voted 8-4, with one abstention, that the same measure was not an adequate endpoint for measuring the NSAID-associated upper GI toxicity of NSAID products. ...