Twelve preclinical and clinical studies recently presented at the annual American Epilepsy Society meeting in Washington, D.C., evaluate the safety and efficacy of rufinamide for the treatment of Lennox-Gastaut syndrome (LGS) and various seizure types in adult and pediatric patients with epilepsy. Eisai, which produces rufinamide, is seeking FDA approval for two indications for the drug -- as an adjunctive treatment for LGS in patients ages four and over, and as an adjunctive treatment for partial-onset seizures with and without secondary generalization in adults and adolescents 12 years of age and over.
Presented at the meeting was a multicenter, double-blind, placebo-controlled, randomized, parallel-group study that evaluated the efficacy and safety of rufinamide as adjunctive therapy in patients with inadequately controlled seizures associated with LGS. Seizure frequency among enrolled patients was monitored during the 28-day baseline phase (BP). In the 84-day double-blind phase, patients were randomized to rufinamide or placebo, with study drug patients titrated based on the patient's weight.