SMC Issues Positive Recommendation on esomeprazole 10mg (Nexium(R)) For Children Aged one to 11 Years old in Scotland With Gastro-Oesophageal Reflux Disease (GORD)

By Astrazeneca, PRNE
Sunday, September 12, 2010

LONDON, September 13, 2010 - AstraZeneca UK welcomes the Scottish Medicines Consortium's (SMC)
positive recommendation for esomeprazole 10mg gastro-resistant granules for
oral solution, sachet (Nexium(R)) for use in children aged one to 11 years
old in Scotland with gastro-oesophageal reflux disease (GORD).(1) The
symptoms of the condition can include the return of food from the stomach
into the mouth, as well as vomiting and poor weight gain.(2) This oral
suspension provides children with this uncomfortable and painful condition
with an additional treatment option and will particularly benefit children
who have difficulty swallowing tablets.(1)

Around four in ten children in the UK are diagnosed with
gastro-oesophageal reflux disease. Without treatment, one in ten infants can
develop complications such as weight loss, dehydration and oesophagitis.(3)
The availability of paediatric sachets will make treatment easier to
administer(1) for parents and children, which assists the recovery process
and will lessen the likelihood of complications occurring, especially for
young children who currently find existing therapies difficult to swallow.

Mark Jones, AstraZeneca UK Marketing Company President, said:
"AstraZeneca is delighted that the SMC has issued a positive recommendation
for esomeprazole 10mg (Nexium) to be used in children aged one to 11 years
old in Scotland with GORD. This decision is good news for children who are
affected by this condition and reflects AstraZeneca's commitment to this
therapy area. AstraZeneca always has the patient in mind, and this simple
formulation has been designed to ensure that it is much easier to swallow,
which will improve quality of life for these children."

Notes to Editors:

About esomeprazole (Nexium)

Esomeprazole (Nexium) is a type of medicine called a proton pump
inhibitor (PPI), which works by decreasing the amount of acid made by the
stomach and gives relief of symptoms such as heartburn and vomiting that are
caused by an excess of acid in the stomach. This allows healing to take
place. The use of this medication does not stop food being digested in the
normal way.(4) Esomeprazole 10mg (Nexium) received a licence in July 2008 for
the treatment of children 1-11 years old with GORD and patients aged 12 years
and older who have difficulty swallowing gastro-resistant tablets.(4)

About gastro-oesophageal reflux disease (GORD)

GORD is a condition where acid from the stomach escapes into the gullet
(oesophagus) causing pain, inflammation and heartburn. Heartburn is a burning
feeling rising from the stomach or lower chest up towards the neck. As many
as 60% of people in the UK have experienced symptoms of heartburn at some
time. The prevalence is higher in women than in men. GORD seems to become
more common with increasing age, the highest incidence being in those aged

In children, the symptoms of the condition can include the return of
stomach contents into the mouth (regurgitation), being sick (vomiting) and
poor weight gain. The condition is also known as acid reflux. Another term
for acid reflux is possetting which occurs more frequently in newborn babies
(approximately four in 10). Without treatment one in ten infants can develop
complications such as weight loss, dehydration and oesophagitis.(3)

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical
business with a primary focus on the discovery, development and
commercialisation of prescription medicines. As a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory and inflammation, oncology and
infectious disease medicines, AstraZeneca generated global revenues of US
$32.8 billion in 2009. For more information please visit:

SMC's recommendation:

ADVICE: following an abbreviated submission[1]

esomeprazole 10mg gastro-resistant granules for oral solution, sachet
(Nexium(R)): is accepted for restricted use within NHS Scotland.

Indication under review: primarily indicated for treatment of
gastro-oesophageal reflux disease in children 1 to 11 years old.

Gastro-oesophageal reflux disease (GORD)

    - Treatment of endoscopically proven erosive reflux oesophagitis

    - Symptomatic treatment of gastro-oesophageal reflux disease

Oral suspension may also be used by patients having difficulty swallowing
dispersed esomeprazole gastro-resistant tablets.

Restricted Advice: the use of esomeprazole for this indication and age
group should be restricted to patients in whom licensed doses of a generic
proton pump inhibitor have been ineffective.

The gastro-resistant granules for oral solution have
demonstrated bioequivalence to the tablet and capsule formulations. Doses of
10mg esomeprazole in children aged 1 to 11 resulted in the same exposure to
drug as seen with the 20mg dose in adolescents and adults. There is no
evidence of comparative efficacy in this population.

The Scottish Medicines Consortium has previously accepted this product
for use in patients in the 12-17 years age group, for the treatment of
erosive reflux oesophagitis, the long-term management of patients with healed
oesophagitis to prevent relapse, and the symptomatic treatment of
gastro-oesophageal reflux disease.


1. Scottish Medicines Consortium decision on esomeprazole (Nexium)

2. Esomeprazole patient leaflet

3.; accessed 16 August 2010

4. Nexium Summary of Product Characteristics

Media Queries: Isabelle Jouin, AstraZeneca +44(0)7770-568-269; Munro & Forster +44(0)207-815-3963

Pharmaceuticals News

AstraZeneca News

will not be displayed