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AstraZeneca has received Swedish Medical Products Agency (MPA) approval for use of esomeprazole (Nexium) in children aged 1-11 years with gastro-oesophageal reflux disease (GERD) in the reference member state of Sweden, with other European Union member states expected to follow.
Nexium will become the first of the proton pump inhibitors (PPI) currently available for the treatment of pediatric GERD to have a specific formulation developed for children.
Children with GERD can experience disruptive symptoms on an every day basis, with a recent AstaZeneca survey indicating that school performance, sleeping habits and social activities were all affected by the condition. Furthermore, the impact of symptoms can be distressing not only for the child but also their parents and/or carers.
Nexium, which is licensed for treatment of GERD, will be available in a 10mg sachet formulation of acid resistant pellets, which are dispersed in liquid. The sachet has a mild citrus-taste and does not contain any artificial flavours. Nexium also provides the added flexibility of administration via nasogastric or gastric tube.
In making its recommendations, the MPA reviewed data from a range of safety and pharmacokinetic studies that investigated symptom improvement and healing as secondary endpoints.
These included a multicentre parallel group study conducted in 109 children aged 1-11 years with endoscopically proven GERD, of whom almost half had erosive esophagitis.
Patients were stratified on the basis of weight and randomised within each group to receive treatment for eight weeks (5 or 10mg esomeprazole < 20kg] and 10 or 20mg [> 20kg]).
Patient diary assessments by the parent/guardian showed that among the 58 patients who had moderate to severe symptoms (heartburn, acid regurgitation and epigastric pain) at baseline, more than 90% experienced symptomatic improvement after treatment with Nexium.
Reflux esophagitis was healed in most patients and Nexium was also shown to be generally well tolerated in the patient population.
In children, Nexium is approved for the treatment of GERD patients aged 1-17 years.
It is also currently under clinical evaluation for the treatment of GERD in even younger children, aged 0-1 year.