November 20, 2008
FDA approves epilepsy drug
The U.S. Food and Drug Administration has approved a new drug, rufinamide -- marketed as Banzel -- to treat severe epilepsy.
The drug is to be used as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome.
This approval offers another treatment option for patients who suffer from these debilitating, severe seizures,Dr. Russell Katz of the FDA's Center for Drug Evaluation and Research said Thursday in a statement.
Lennox-Gastaut syndrome is a severe form of epilepsy that usually begins before age 4. The FDA said most children with the syndrome experience some degree of impaired intellectual functioning or information processing.
A 4-month clinical trial studying patients ages 4 to 30 found approximately a 41 percent reduction of tonic and atonic seizure frequency and a 20 percent reduction of total seizure frequency.
Banzel is manufactured by Eisai Medical Research Inc., Woodcliff Lake, N.J.