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| | | ![]() Treatment Boom Continues As FDA Clears Two New Epilepsy Drugs LANDOVER, MD. -- October 2, 1997 -- In what is already an unprecedented year for new drug and device approvals for the treatment of seizures and epilepsy, the United States Food and Drug Administration (FDA) has cleared two additional medications for marketing in the United States. "It's an exciting time full of hope for people living with seizures that until now have defied successful treatment," explained Paulette V. Machara, chief executive officer of the Epilepsy Foundation of America. "We are gratified that two new options have been found safe and effective." The medications just approved are Gabitril (tiagabine) and Carbatrol (a sustained-release form of carbamazepine). Gabitril has been cleared as add-on therapy in the treatment of partial seizures, a form of epilepsy that is difficult to treat and has negative social consequences for sufferers. Carbamazepine is primary therapy for partial and some types of generalized seizures. Partial seizures produce distorted awareness and temporary inability to respond to the environment in a normal way. The seizures are open to misinterpretation, often mistaken for antisocial behavior and the cause of considerable inconvenience, embarrassment and even abuse to people who experience them. Within the past 12 months, the FDA has also approved Topamax (topiramate), Diastat Rectal Gel (the first epilepsy therapy for emergency use in the home) and an electrical stimulation device (vagus nerve stimulator), a completely new form of treatment for seizures. "We're making important strides in controlling seizures," Machara explained. "The quality of life for people with epilepsy is improving thanks to our nation's earlier commitment to research. We are unaware of any other medical condition in which there have been this many new treatment approvals within a single year. However, EFA's concern is that the momentum be sustained and that we begin to learn more about the cause and prevention of epilepsy."
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