Novartis Pharmaceuticals Corporation has received an approval from the US Food and Drug Administration for Trileptal (oxcarbazepine) tablets and oral suspension as adjunctive therapy (use in combination with other antiepileptic drugs) in the treatment of partial seizures in children as young as two-years old with epilepsy.
"The approval of Trileptal as adjunctive therapy in children as young as two represents an advance in the treatment of paediatric epilepsy," said Tracy Glauser, professor of paediatrics and neurology, director of the Comprehensive Epilepsy Programme, Cincinnati Children's Hospital Medical Centre and Trileptal clinical trial investigator. "Trileptal has a proven track record of effective seizure control with favourable safety and tolerability and now those benefits can be extended to children as young as two years of age."
The new Trileptal indication is based on data from a multicentre, rater-blind, randomized study. The study evaluated 128 paediatric patients who were still experiencing partial seizures while taking up to two concomitant AEDs. Patients received either high-dose (60 mg/kg/day) or low-dose (10 mg/kg/day) Trileptal oral suspension. High-dose Trileptal adjunctive therapy was significantly more effective in controlling partial seizures in young children than treatment with low-dose Trileptal, and both doses were generally well tolerated, claims a company release.
"Treating epilepsy in children has different issues from treating adults -- the differences primarily relate to the growth and development process, which can affect or be affected by epilepsy treatment. The selection of AEDs for children with epilepsy should therefore be based on clinical studies specifically designed to evaluate efficacy, safety, tolerability and pharmacokinetics in young patients," said Angus Wilfong, professor of neurology and paediatrics, Baylor College of Medicine, Texas Children's Hospital.
Approximately 300,000 children aged 14 and younger have epilepsy and approximately 25% of children with epilepsy do not have adequate seizure control.
Trileptal is already indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children four years of age and older with epilepsy. Trileptal was the first AED in 25 years to be approved for use as monotherapy in children and has been available in the United States since February 2000.