Jane S. Ricciuti, RPh, MS


January 20, 2005

In This Article

Anti-Ulcer Agents and Acid Suppressants

(esomeprazole) Capsules

Manufacturer: AstraZeneca

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 11/24/04)

New Indication: This supplemental new drug application provides for the use of Nexium (esomeprazole) delayed-release capsules for the risk reduction of nonsteroidal anti-inflammatory drug (NSAID)-associated gastric ulcers.

Dosing: Esomeprazole 20 or 40 mg once daily

Clinical Summary: In 2 multicenter, double-blind, placebo-controlled studies, esomeprazole was studied in 1429 endoscopically confirmed nonulcerous patients at risk of developing gastric and/or duodenal ulcers associated with continuous use of non-selective and COX-2 selective NSAIDs. Patients receiving NSAIDs and treated with esomeprazole 20 mg or 40 mg once daily experienced significant reduction in gastric ulcer occurrences relative to placebo treatment at 26 weeks. No additional benefit was seen with esomeprazole 40 mg over esomeprazole 20 mg. These studies did not demonstrate significant reduction in the development of NSAID-associated duodenal ulcer due to the low incidence.

Nexium (esomeprazole) Capsules Labeling

Nexium (esomeprazole) Capsules


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