The Food and Drug Administration on Monday approved marketing of an adult epilepsy drug for the treatment of children with partial onset seizures.
The drug, topiramate, was approved for children ages 2 to 12 who suffer from partial onset seizures, one of 20 types of seizure disorders.
Extending the use of topiramate to pediatric patients is an important advance for treatment of children with epilepsy, said officials of the Epilepsy Foundation.
"Uncontrolled partial seizures may severely [affect] a child's intellectual and social development," said Dr. Steven C. Schachter, chairman of the Epilepsy Foundation medical advisory board.
"We're pleased that there now is another treatment option for helping to bring such seizures in young patients under better control," he said.
There already are drugs to treat pediatric epilepsy patients, but topiramate is the first approved for partial onset seizures for patients as young as 2, the FDA said. About 750,000 pediatric patients have partial onset seizures.
About 2.3 million Americans have epilepsy, and about a third of them are children. About 500,000 patients achieve full seizure control with medication, another 1 million get partial relief, while about 600,000 have seizures that do not respond to drugs, according to the Epilepsy Foundation.
Topiramate already is marketed for adult patients under the brand name Topamax, manufactured by Ortho-McNeil Pharmaceuticals of Raritan, N.J.