MONDAY, Oct. 31 (HealthDay News) -- The U.S. Food and Drug Administration approved Trileptal (oxcarbazepine) tablets and oral suspension for use in combination with other drugs to treat partial seizures in epileptic children as young as age two.
The drug's maker, Novartis, made the announcement on Monday. Trileptal is already indicated for use as monotherapy or adjunctive therapy for the treatment of partial seizures in adults and children with epilepsy aged four and older.
The new Trileptal indication is based on a study of 128 pediatric patients who were given either high-dose (60 mg/kg/day) or low-dose (10 mg/kg/day) Trileptal oral suspension, according to a Novartis statement.
Tracy Glauser, M.D., of Cincinnati Children's Hospital Medical Center, and colleagues found high-dose Trileptal adjunctive therapy "significantly more effective" in controlling partial seizures in young children than low-dose Trileptal. The study is due to be published in an upcoming issue of Neurology.
The approval of Trileptal for two-year-olds represents "an advance in the treatment of pediatric epilepsy," Glauser said in the statement. Trileptal has been available in the United States since 2000.
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