Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved Depakote ER (divalproex sodium extended release) tablets for sole and adjunctive therapy to treat complex partial seizures in isolation or in association with other types of seizures and simple and complex absence seizures in children, ages 10 and above, with epilepsy.
Depakote ER is the once-daily formulation of Depakote (divalproex sodium delayed release) tablets, which has been a leading medication for the treatment of epilepsy since its initial approval in 1983. Depakote ER was approved for migraine prevention in adults in 2000 and for epilepsy in adults in 2002.
"Depakote ER improves seizure control in adult patients with epilepsy, and it's exciting that once-a-day dosing can now offer the same benefit to children with epilepsy," said John Pellock, professor of pediatrics and neurology, Virginia Commonwealth University, Medical College of Virginia. "In a pharmacokinetic study of Depakote ER in pediatric patients, the clinical researchers found that Depakote ER produces consistent, therapeutic concentrations of medication throughout an entire 24-hour cycle. I have also found that once-a-day dosing is much more convenient for children and their parents."
Approximately two million Americans have some form of epilepsy, with approximately 50 percent of newly diagnosed cases of epilepsy reported in children under age 18. Epilepsy is a chronic neurological condition that can result in periodic disturbances in the normal electrical functions of the brain, resulting in seizures, which are caused by unusually intense and intermittent electrical energy in the brain. Seizures can impact a person's consciousness, body movements or sensations for short periods of time.
"The approval of Depakote ER for use in pediatric patients demonstrates Abbott's commitment to addressing the needs of the wide range of patients with epilepsy," said Bill Dempsey, senior vice president, Pharmaceutical Operations, Abbott Laboratories. "Abbott continues to have an active research program in CNS disorders and is committed to developing the next generation of treatments for a variety of neurological disorders."