FDA approves AstraZeneca’s intravenous Nexium

Nexium IV (esomeprazole magnesium) is now approved as an intravenous infusion or injection for the short-term treatment of gastroesophageal reflux disease (GERD) patients, with a history of erosive esophagitis, who are unable to take capsules.

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

“Hospitalized patients with GERD are often unable to take their oral medication,” said Dr David Metz, 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.”

The approval was based, in part, on the findings of four multi-center studies comparing the pharmacodynamic efficacy of the intravenous formulation with Nexium delayed-release capsules, in GERD patients with or without a history of erosive esophagitis. They demonstrated that, after ten days of once-daily administration, Nexium IV 20mg and 40mg are similar in their ability to suppress acid to the corresponding oral dosage form of Nexium.