AstraZeneca has announced that the FDA has approved a new indication for the prescription proton pump inhibitor NEXIUM® (esomeprazole magnesium) for the treatment of Zollinger-Ellison Syndrome (ZES). NEXIUM already is indicated for the treatment of 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.ZES is a rare but serious chronic condition characterized by the development of tumors that secrete excessive levels of gastrin, a hormone that stimulates acid production by the stomach.”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,” said David C. Metz, MD, Professor of Medicine, and Director of the Acid-Peptic Program, Division of Gastroenterology, University of Pennsylvania Health System. “NEXIUM provides early, effective, and sustained acid suppression to help in the management of this disease.”The new indication for NEXIUM is based on clinical data in which twenty- one patients received one of several doses of NEXIUM, depending on their symptoms and the degree of their acid output. The twelve-month, open-label trial demonstrated that NEXIUM effectively maintains basal acid output control in this patient population. NEXIUM(R) (esomeprazole magnesium) was well tolerated throughout the trial.
