LONDON, September 13, 2010 /PRNewswire/ -- 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 55-64.(3)
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)
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ADVICE: following an abbreviated submission
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. http://www.refluxadvice.co.uk; accessed 16 August 2010
4. Nexium Summary of Product Characteristics
CONTACT: Media Queries: Isabelle Jouin, AstraZeneca +44(0)7770-568-269;Munro Forster +44(0)207-815-3963