FDA Approves Nexium for Zollinger-Ellison Syndrome

FDA Approves Nexium for the Treatment of Zollinger-Ellison Syndrome

WILMINGTON, Del., October 12, 2006 -- AstraZeneca today announced that the US Food and Drug Administration (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 (esomeprazole magnesium) was well tolerated throughout the trial.

About ZES

ZES affects fewer than three out of every million Americans,(1) but it is difficult to treat and may be life-threatening. Most people with ZES are prone to recurrent duodenal ulcers; other symptoms include abdominal pain, diarrhea, and increased fat in the stools. In most instances, ZES develops randomly for unknown reasons. Approximately one-quarter to one-third of cases are linked to a genetic syndrome known as multiple endocrine neoplasia type 1 (MEN-1). Nearly one-half to two-thirds of people with ZES develop cancerous gastrinomas.(2) These tumors generally arise within the pancreas and/or the duodenum, and may spread to the lymph nodes or liver.

About Nexium (esomeprazole magnesium) delayed-release capsules

Nexium is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions. Nexium also is indicated for reducing the risk of gastric (stomach) ulcers developing among at-risk patients on continuous non-steroidal anti-inflammatory drug (NSAID) therapy. Patients are considered to be at risk if they are 60 and over, or if they have a history of previous stomach ulcers. And now Nexium is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. Dosage regimens should be adjusted to individual patient needs.

The most frequently reported adverse events with Nexium include headache, diarrhea, and abdominal pain.

For full Prescribing Information for Nexium please visit www.Nexium-us.com.

References:

  1. Del Valle J, Scheiman JM. Zollinger-Ellison Syndrome. In: Yamada T, Alpers DE, Kaplowitz N, Laine L, Owyang C, Powell DW, eds. Textbook of Gastroenterology. Vol 1. 4th ed. Philadelphia, PA: Lippincott, Williams, and Wilkins; 2003:1377- 1394.
  2. Zollinger-Ellison Syndrome. National Organization for Rare Disorders. NORD Web site. Available at: www.rarediseases.org/search/rdbdetail_abstract.html?disname=Zollinger%2 0Ellison%20Syndrome.

Source: AstraZeneca

Posted: October 2006

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