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FDA OK's Nexium for new use

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Published: Oct. 12, 2006 at 5:27 PM

WILMINGTON, Del., Oct. 12 (UPI) -- AstraZeneca said Thursday the U.S. Food and Drug Administration has approved a new use for Nexium to treat Zollinger-Ellison Syndrome.

ZES is a rare, serious disorder marked by the development of tumors that secrete excessive levels of gastrin, a hormone that stimulates acid production by the stomach.

The new indication is supported by a yearlong trial involving 21 patients that showed Nexium maintains basal acid output control in people who have the disorder.

AstraZeneca's blockbuster drug is currently approved for gastroesophageal reflux disease (GERD) in adults and children ages 12 to 17 and to reduce the risk of NSAID-associated gastric ulcers in at-risk patients.

"Zollinger-Ellison Syndrome is the prototypical gastric acid hypersecretory condition. Patients with this condition require long-term antisecretory therapy to reduce their acid output to levels that are not injurious," David Metz, professor of medicine at the University of Pennsylvania Health System, said in a statement issued by the company. "Nexium provides early, effective, and sustained acid suppression to help in the management of this disease."

© 2006 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.

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