NEW YORK -- November 18, 2008 -- The US Food and Drug Administration (FDA) has approved rufinamide (Banzel) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children aged 4 years and older, and adults.
The approval is based on a randomised, double-blind, placebo-controlled clinical trial of 138 patients, aged 4 to 30 years, who experienced seizures associated with LGS. Patients were treated with rufinamide as adjunctive therapy or given a placebo. Results of the study showed a 42.5% median reduction in frequency of drop attacks compared with a 1.4% median increase for patients taking placebo.
"People living with LGS need more treatment options," said lead investigator of the study Tracy Glauser, MD, Comprehensive Epilepsy Program, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
"What's exciting about this study is that rufinamide was effective and generally well tolerated in children with LGS whose seizures were previously uncontrolled on other multiple antiepileptic medications."
The primary efficacy variables were as follows:
· The percent change in total seizure frequency per 28 days
· The percent change in tonic-atonic seizure frequency per 28 days
· Seizure severity from the Parent/Guardian Global Evaluation of the patient's condition
Results of the primary efficacy variable analyses were as follows:
· Patients treated with rufinamide had a 32.7% median reduction in total seizure frequency per 28 days in the double-blind phase relative to the baseline phase compared with 11.7% of placebo-treated patients (P < .002).
· Patients treated with rufinamide had a 42.5% median reduction and placebo-treated patients had a 1.4% median increase in tonic-atonic seizure frequency per 28 days in the double-blind phase relative to the baseline phase (P < .0001).
· An improvement in seizure severity was observed in 53.4% of patients treated with rufinamide compared with 30.6% of the placebo-treated patients in the Seizure Severity Rating from the Global Evaluation of the patient's condition.
The most commonly observed adverse reactions were headache, dizziness, fatigue, somnolence, and nausea.
SOURCE: Eisai
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