FDA Approves Rufinamide as Adjunctive Treatment for Lennox-Gastaut Syndrome

Eisai Corporation of North America, a U.S. subsidiary of Eisai Co., Ltd, announced on November 14th that the Food and Drug Administration (FDA) approved BANZEL™ (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. BANZEL is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs). It is believed to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures.

A double-blind, placebo-controlled pivotal study of LGS patients treated with BANZEL as adjunctive therapy showed a 42.5 percent median reduction in frequency of drop attacks, seizures that cause a person to lose consciousness and fall to the ground, compared with a 1.4 percent median increase for placebo-treated patients.

LGS is one of the most severe forms of childhood epilepsy and characterized by multiple and frequent seizures. Children usually experience the onset of LGS between the ages of 1 and 5 years old. LGS accounts for 1 to 4 percent of all childhood epilepsy cases; approximately 300,000 children under the age of 14 in the U.S. have epilepsy. The condition is difficult to treat, with patients often taking multiple AEDs in attempts to control the seizures.

Reviewed by Epilepsy Foundation Professional Advisory Board Member, Brian Alldredge, PharmD, Professor of Clinical Pharmacy & Neurology & Associate Dean, Academic Affairs, School of Pharmacy, University of California, San Francisco