FDA Approves Nexium I.V. for GERD in Pediatric and Adolescent Patients

FDA Approves Nexium I.V. (Esomeprazole Sodium) for the Treatment of Gastroesophageal Reflux Disease (GERD) With Erosive Esophagitis in Pediatric and Adolescent Patients

WILMINGTON, Del.--(BUSINESS WIRE)--May 2, 2011 - AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved the use of Nexium I.V. (esomeprazole sodium) for Injection for children ages greater than 1 month old for the short-term treatment of gastroesophageal reflux disease (GERD) with erosive esophagitis when oral therapy is not possible or appropriate.1 Nexium I.V. is the first proton pump inhibitor approved for children under one year old.

GERD is a condition in which the contents of the stomach back up into the esophagus.2 Erosive esophagitis, a condition associated with GERD, refers to inflammation of the esophagus that may occur after exposure to acidic reflux of stomach contents. For children and adults, symptoms of GERD often include heartburn, regurgitation and upset stomach. Common GERD symptoms in infants include irritability, vomiting, difficulty swallowing, and weight loss or poor weight gain.

"This approval of Nexium I.V. for the treatment of children 1 month to 17 years old who are suffering from GERD with erosive esophagitis, gives physicians an important option in the treatment of infants and children," said Marta Illueca, MD, FAAP, executive director of gastrointestinal disorders for AstraZeneca.

"This approval represents an important contribution to an unmet medical need for infants in particular. While some reflux and regurgitation are normal in infants and may not require medical treatment, persistent GERD symptoms can be very uncomfortable and cause damage to the esophagus, just as they can in older patients. Close medical supervision is key in the appropriate diagnosis and choice of treatment for these infants," continued Illueca.

For first-line treatment of pediatric GERD, families are encouraged to try lifestyle modifications, such as smaller, more frequent feedings or dietary changes. If these methods fail, physicians until now have very few approved pharmacological options. Nexium I.V. is the first proton pump inhibitor approved for use in infants younger than 1 year old.

Nexium I.V. for Injection is an alternative to oral therapy when oral therapy is not possible or appropriate and is administered in the hospital by a health care professional. Treatment with Nexium I.V. for more than 10 days has not been studied.

About GERD

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 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 cross-sectional survey, looked at the prevalence of regurgitation in healthy infants 13 months old and younger. The study included a total of 948 parents of infants 13 months old and younger. Peak regurgitation was reported 23% of the time at 6 months. A proportion of these infants may have persistent symptoms diagnosed as GERD.3 Close medical supervision is key in the proper diagnosis and choice of treatment for these infants.

Important Safety Information

  • Nexium (esomeprazole magnesium) is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles
  • Symptomatic response to therapy does not preclude the presence of gastric malignancy
  • Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which Nexium is an enantiomer
  • Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine
  • Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, and digoxin)
  • Concomitant use of Nexium and atazanavir or nelfinavir is not recommended because the plasma concentrations and therapeutic effects of those antiretroviral drugs may be reduced
  • Nexium may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered
  • Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels
    Nexium may increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction
  • Nexium IV should be used only when the oral therapy with Nexium is not possible or appropriate.
  • The adverse reactions reported at a frequency of 1% or greater with Nexium IV were headache, flatulence, nausea, abdominal pain, injection site reaction, diarrhea, dry mouth, dizziness/vertigo, constipation and pruritus

Approved Use

Nexium I.V. is a proton pump inhibitor indicated for the treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis in adults and pediatric patients greater than one month of age, when oral therapy is not possible or appropriate.

Please read the full Prescribing Information and discuss it with your child's doctor or health care professional.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information about AstraZeneca in the U.S. or our AZ&Me™ Prescription Savings programs, please visit www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

Nexium I.V. is a registered trademark of the AstraZeneca group of companies.

1 Nexium I.V. Prescribing Information

2 WebMD: Gastroesophageal Reflux Disease. Available at http://www.webmd.com/heartburn-gerd/guide/reflux-disease-gerd-1. Accessed on April 22, 2011.

3 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 Pediatric Adolesc Med 2000; 154:150-154.

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Contact: AstraZeneca
Media Inquiries:
Blair Hains +1-302-885-1813

Posted: May 2011

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