WILMINGTON, Del., Feb. 28 /PRNewswire-FirstCall/ -- AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved the use of NEXIUM(R) (esomeprazole magnesium) in children ages 1 to 11 years old for the short-term treatment of gastroesophageal reflux disease (GERD) for up to 8 weeks,(1) helping to address an important unmet need for pediatric patients.
NEXIUM received approval in April 2006 for adolescents 12 to 17 years old for the treatment of GERD, a condition in which the contents of the stomach back up into the esophagus. Symptoms of GERD often include heartburn, regurgitation and upset stomach.
“GERD has become increasingly common in children, and, if left untreated, can lead to potentially serious complications such as erosive esophagitis,” said Mark A. Gilger, MD, Chief of Service, Gastroenterology, Hepatology and Nutrition, Texas Children’s Hospital. “GERD isn’t just a condition that affects adults. Researchers estimate children ages 3 to 17 years old report GERD symptoms roughly 2% to 8% of the time."(2) The availability of a proven, effective treatment like NEXIUM with an established safety profile is an important step in the treatment of this chronic condition.”
The FDA has also approved a new 10 mg dose formulation of NEXIUM for Delayed-Release Oral Suspension for use in children 1 to 11 years old. This 10 mg dose formulation is in addition to the 20 and 40 mg NEXIUM for Delayed- Release Oral Suspension, which were approved in October 2006 for use in adolescent patients 12 to 17 years old, as well as adults. The new 10 mg dose formulation contains esomeprazole magnesium, the same active ingredient used in NEXIUM Delayed-Release Capsules. The 10 mg dose is a granular formulation that is mixed with water to form a suspension that is administered orally or via enteral (feeding) tubes. The 10 mg dose of NEXIUM(R) (esomeprazole magnesium) for Delayed-Release Oral Suspension will be available later this year. The 20 mg and 40 mg doses are currently available by prescription.(1)
“This dosing alternative of NEXIUM for oral suspension allows patients, such as children and the elderly, who are unable to swallow capsules or tablets to have an alternative treatment option for controlling their GERD,” said Marta Illueca, MD, FAAP, NEXIUM Brand Medical Director, AstraZeneca Pharmaceuticals, LP, U.S. “Today’s FDA approvals build upon AstraZeneca’s commitment to better understanding the many patient populations affected by GERD and providing valuable treatment options for each of these groups.”
Safety Profile
The safety and tolerability of NEXIUM in children 1 to 11 years old was evaluated in a multicenter, randomized, double-blind, open-label, parallel- group study in which patients (n=109) with a history of endoscopically-proven GERD were treated with either 5 mg or 10 mg NEXIUM (children <20 kg) or 10 mg or 20 mg NEXIUM (children greater than or equal to 20 kg) once daily for 8 weeks. In these patients the recommended dosage schedule in the short-term treatment of symptomatic GERD is 10 mg once daily for up to 8 weeks; for the healing of erosive esophagitis it is 10 mg once daily for up to 8 weeks for patients whose weight is <20 kg and 10 mg or 20 mg once daily for up to 8 weeks for patients who weight is greater than or equal to 20 kg. The most frequently reported treatment-related adverse events in this age group were diarrhea, headache and sleepiness. No new safety concerns were identified.(3)
In addition, the use of NEXIUM in children 1 to 11 years old is supported by extrapolation of results from adequate and well-controlled studies in adults and a pharmacokinetic study in children 1 to 11 years old.
For first-line treatment of pediatric GERD, 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 GERD
Approximately 60 million American adults experience gastroesophageal reflux disease (GERD) symptoms more than twice a week.(4) GERD is characterized by frequent and persistent heartburn, which occurs when the lower esophageal sphincter (the valve separating the esophagus and stomach) does not close properly, allowing acid to back up into the esophagus. GERD is chronic and, if left untreated, may potentially lead to more serious medical conditions.
GERD can lead to potentially serious complications in children, such as erosive esophagitis. The exact prevalence and frequency of GERD in children is unknown, as there are very few medical studies reporting the incidence of GERD symptoms in children. One study, a practice-based survey, looked at the prevalence of GERD symptoms in children 3 to 17 years old. The study included a total of 566 parents of 3 to 9 year old children, 584 parents of 10 to 17 year old children, and 615 children 10 to 17 years old. Across the varying age groups, weekly symptoms (heartburn, epigastric pain and regurgitation) were reported 2% to 8% of the time.(2)
About NEXIUM(R) (esomeprazole magnesium)
In adults, 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 received approval in April 2006 for the short-term treatment (up to 8 weeks) of GERD in adolescent patients ages 12 to 17. NEXIUM is now approved for the short-term treatment (up to 8 weeks) of GERD in children ages 1 to 11. The approvals are supported by extrapolation of results from adequate and well-controlled studies that supported the approval of NEXIUM for adults, and safety and pharmacokinetic studies. The safety and effectiveness of NEXIUM for the treatment of GERD in patients <1 year of age have not been established. The safety and effectiveness of NEXIUM for other pediatric uses have not been established.
In adults, the most frequently reported adverse reactions with NEXIUM include headache, diarrhea, and abdominal pain. In patients 1 to 17 years of age, the most frequently reported adverse reactions with NEXIUM include headache, diarrhea, abdominal pain, nausea, and sleepiness. Symptomatic response to therapy does not preclude the presence of gastric malignancy. NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information.
For more information visit: www.NEXIUM-US.com.
For additional information, questions, or to request a copy of the NEXIUM prescribing information, please contact the Information Center at AstraZeneca at 1-800-236-9933, Monday through Friday, from 8 a.m. to 7 p.m. ET, excluding holidays.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people’s lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information visit www.astrazeneca-us.com.
This press release contains forward-looking statements with respect to AstraZeneca’s business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company’s Annual Report/Form 20-F for 2005.
NEXIUM is a registered trademark of the AstraZeneca group of companies. (C) 2008 AstraZeneca LP. All rights reserved.
(1) NEXIUM Prescribing Information. (2) Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice- based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med 2000; 154:150-154. (3) Gilger, M. Tolia, Vasundhara. Safety and Tolerability of Esomeprazole in Children with Gastroesophageal Relfux Disease. Journal of Pediatric Gastroenterology and Nutrition. October 2006. Volume 43 (4). (4) Shaker R, Castell DO, Schoenfeld PS, Spechler SJ. Nighttime heartburn is an under-appreciated clinical problem that impacts sleep and daytime function: The results of a Gallup survey conducted on behalf of the American Gastroenterological Association. American Journal of Gastroenterology 2003;98(7):1487-1493.
