Nexium Approved for Children 12 to 17 For Short-Term Treatment of GERD
FDA Approves Use of Nexium in Children Ages 12 to 17 For Short-Term Treatment of GERD
WILMINGTON, Del., May 1, 2006 -- AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved the use of Nexium (esomeprazole magnesium) delayed release capsules, in children ages 12 to 17 for the short-term treatment of gastroesophageal reflux disease (GERD).
"GERD isn't just a disease that affects adults, it also is common in childhood and can be problematic for adolescents as well," said Marta Illueca, MD, F.A.A.P., Director, Medical Science, GI Respiratory, AstraZeneca. "We believe today's approval is an important step in providing a valuable treatment option for thousands of patients across the country."
The safety of Nexium in adolescents ages 12 to 17 was evaluated in a multicenter, randomized, double-blind parallel group study in which a total of 149 patients, ages 12 to 17, with clinically diagnosed GERD were treated with either Nexium 20 mg or Nexium 40 mg once daily for up to eight weeks. The use of Nexium in children ages 12 to 17 years is supported by extrapolation of results from adequate and well-controlled studies in adults and additional safety and pharmacokinetics studies in adolescents' ages 12 to 17.
The most frequently reported treatment related adverse events were headache, abdominal pain, diarrhea and nausea. No safety concerns were identified.
About Pediatric GERD
Gastroesophageal reflux disease, commonly referred to as GERD, is a condition in which the contents of the stomach back up into the esophagus. GERD affects approximately eight percent of children in the United States between the ages of 12 and 17, about three million children. In children, GERD manifests mostly as vomiting/regurgitation (at times, persistent), as well as decreased appetite or refusal to eat. (1) Other conditions such as asthma also may be signs of the disease. For first-line treatment, families are encouraged to try lifestyle modifications, such as smaller, more frequent meals or dietary changes. If these methods fail, physicians may recommend over-the-counter antacids or prescribe certain medications that suppress acid.
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 ulcer.
The safety and efficacy of Nexium for the treatment of symptomatic GERD in children less than 12 years of age have not been established. The safety and efficacy of Nexium for other pediatric uses have not been established.
The most frequently reported adverse events with Nexium include headache, diarrhea, and abdominal pain.
References
(1) Rudolph. J Pediatr Gastroenterol Nutr 2001;32:S1-31.
Source: AstraZeneca
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