AstraZeneca PLC has won FDA approval to market its esomeprazole (Nexium) ulcer pill as a treatment that reduces the risk of ulcers developing in patients on nonsteroidal anti-inflammatory drugs (NSAIDs).
A total of 1,429 patients ranging in age from 19 to 89 years were evaluated in two separate multi-center, double-blind, placebo-controlled clinical studies. Patients were given either a nonselective or COX-2 selective NSAID along with either esomeprazole 20 mg or 40 mg once a day. Esomeprazole 20 mg and 40 mg demonstrated comparable benefits in providing excellent risk reduction with the proportion of NSAID patients remaining free of gastric ulcers ranging from 95.4% to 96.7% in one study and 94.7% to 95.3% in the second study.