Banzel Approved To Treat Severe Form of Epilepsy

The U.S. Food and Drug Administration (FDA), has approved Banzel (rufinamide) as an added treatment for a severe form of epilepsy known as Lennox-Gastaut syndrome.

The FDA has given Eisai Medical Research Inc., of New Jersey, the maker of Banzel, “orphan drug status.” A status reserved for drugs that are intended to treat disorders and/or conditions that affect less than 200,000 people in the U.S.

Lennox-Gastaut syndrome is a rare and severe form of epilepsy in children. The disorder usually begins before 4 years of age. And can be caused by a head injury, central nervous system infection, brain malformations, and inherited degenerative or metabolic conditions.

In 30-35 percent of patients, no cause can be found, according to the FDA.

Epilepsy affects two million people in the United States, a disorder characterized by seizures. Seizures occur when nerves in the brain fire spontaneously, causing symptoms ranging from shaking of a single arm or leg to loss of consciousness and generalized spasms.

The drug received agency approval based on the outcome of a four-month clinical trial that included patients varying in age from 4 to 30. Patients taking Banzel had improved seizure control and 41 percent fewer tonic (and atonic) seizures and 20 percent less seizures of any type, compared to patients who took a placebo.

Most commonly noted side effects include: double vision, drowsiness, fatigue, headache, and nausea, problems walking and vomiting.

Banzel, like other approved anti-seizure drugs - will carry a warning advising patients that it may increase the risk of suicidal thoughts and behaviors. Patients should receive a patient medication guide outlining the risks of suicidal thoughts and behaviors associated with this class of drugs, said the FDA.

Patients that have this form of epilepsy experience periods of recurring seizures mixed with short lasting seizure-free periods. They suffer from varying types of seizures which include tonic (grand mal seizures), atonic, atypical absence and myoclonic.

In 2007, more than 10 million Americans took FDA-approved epilepsy drugs. #