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FDA Approves Intravenous Formulation of Esomeprazole

April 1, 2005 - Wilmington, DE - AstraZeneca today announced that a new administration formulation for its prescription proton pump inhibitor Nexium (esomeprazole magnesium) has been approved by the US Food and Drug Administration (FDA). Nexium I.V. is now approved as an intravenous infusion or injection for the short-term treatment (up to 10 days) of gastroesophageal reflux disease (GERD) patients, with a history of erosive esophagitis, who are unable to take capsules.

Nexium I.V. (esomeprazole sodium) for injection is administered once daily as either a 10 to 30 minute intravenous infusion or by intravenous injection (no less than 3 minutes). Treatment is given for up to 10 days and does not require an in-line filter.

"Hospitalized patients with GERD are often unable to take their oral medication," said David C. Metz, M.D., Professor of Medicine in the Division of Gastroenterology at the Hospital of the University of Pennsylvania. "The availability of Nexium in an intravenous formulation provides these patients with an effective alternative route of administration that they can tolerate easily."

“AstraZeneca is pleased to be able to make this new intravenous formulation of Nexium available to healthcare professionals,” said Mark Sostek, MD, Senior Medical Director for AstraZeneca. “We are dedicated to providing healthcare professionals and the patients they treat with innovative treatment options.”

About Nexium I.V. (esomeprazole sodium) for injection
The approval of Nexium I.V. was based, in part, on the findings of four multicenter, open-label, two-period crossover studies. These studies compared the pharmacodynamic efficacy of the intravenous formulation with Nexium delayed-release capsules at corresponding doses of 20 mg and 40 mg in GERD patients with or without a history of erosive esophagitis. They demonstrated that, after 10 days of once-daily administration, Nexium I.V. 20 mg and 40 mg are similar in their ability to suppress acid to the corresponding oral dosage form of Nexium . There were no relevant changes in acid suppression when switching between intravenous and oral dosage form.

Source: AstraZeneca

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