For the Media:

Topamax Approval Latest of FDA Actions to Improve Lives of People with Seizures

Landover, Md., June 30, 2005 -- There are no magic answers to the control of recurring seizures or epilepsy, a common neurological disorder that affects 2.7 million people in the United States. But today's announced FDA approval of Topamax (topiramate) as initial monotherapy in people ages 10 and above with partial onset or primary generalized tonic-clonic seizures (convulsions) significantly raises the chances of early treatment success for patients newly diagnosed with the disorder.

The Epilepsy Foundation estimates that as many as 200,000 new cases of epilepsy develop each year in the United States. According to the Foundation's president, Eric R. Hargis, doctors are in need of every new treatment option possible in order to provide the critical individualized care that epilepsy demands.

"Epilepsy is a family of more than 40 syndromes," Hargis said. "The diversity of these conditions and the brain's complex chemistry present a considerable challenge in bringing seizures under medical control. It is gratifying to know that more people with epilepsy will now have the chance of being successfully treated early in the treatment process."

"The Topamax approval is the latest in several FDA actions likely to improve quality of life for people with epilepsy. Earlier actions have included marketing approval for a new medication for seizures in adults, and the approval of a pediatric indication for another of the newer generation of epilepsy medications," he said.

Among potential side effects associated with Topamax are confusion, sleepiness, fatigue, dizziness, double vision, nausea, unsteadiness, rash and behavioral changes.

Globally, epilepsy is second only to headache (including migraine) among neurological disorders seen in primary care settings. The disorder and its treatment produce a health related quality of life – measured in days of activity limitation, pain, depression, anxiety, reduced vitality, and insufficient sleep or rest – similar to arthritis, heart problems, diabetes, and cancer.

The Epilepsy Foundation is the national health voluntary that helps individuals and families affected by seizures in coping with the impact of the disorder on their lives. The organization, with its national network of local affiliates, leads the fight for more research, better therapies, the removal of social barriers, and access to quality care, so not another moment will be lost to seizures.

For more information about epilepsy visit http://www.epilepsyfoundation.org or call (800) 332-1000.

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