The Scottish Medicines Consortium has endorsed the restricted paediatric use under the country’s National Health Service of AstraZeneca’s Nexium in patients aged 12-17 years with gastro-oesophageal reflux disease.
Specifically, Nexium (esomeprazole) has been accepted 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. But use has been restricted to patients in whom generic proton pump inhibitors have been ineffective.
This guidance follows the EU Regulation on Paediatric Medicines, which came into force in January 2007 with the aim of increasing the availability of medicines specifically licensed for use in children and adolescents. According to the firm, the pharmacokinetics of Nexium in adolescents has been shown to be similar to those seen in adults.
Others making it through
Meanwhile, the SMC has also given the thumbs up to Prostrakan’s testosterone gel Tostran for restricted use in male hypogonadism when testosterone deficiency has been confirmed by clinical symptoms and laboratory analyses, and Ranbaxy’s formoterol inhalation powder Easyhaler Formoterol, for the treatment of asthma in patients on inhaled corticosteroids.