--New 10 mg Dose Formulation for Oral Suspension Also Approved--
WILMINGTON, Del., Feb. 28 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE:
AZN) 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: http://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 http://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.
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca-us.com
http://www.NEXIUM-US.com
http://www.prnewswire.com/comp/985887.html /
CONTACT:
Blair Hains, +1-302-885-1813, or Corey
Windett, +1-302-885-0034, both of AstraZeneca
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