FDA Approves Drug for Severe Epilepsy

Epilepsy is a brain disorder caused by abnormal brain signals which manifests itself in physical symptoms. During the episodes, or seizures, the neuronal signals may occur as many as 500 times a second compared to the normal rate of about 80 times per second. The symptom that most people recognize during the seizures is the muscle spasms that cause the patient to shake or twitch, sometimes including convulsions and unconsciousness.
There are more than 2 million people in the United States who have had seizures or have been diagnosed with epilepsy. The exact cause of epilepsy has not been discovered but it is somehow related to the electrical impulses of the brain. The cause could be related to genetics, caused by injury, illness, or some aspect of brain development.

Some types of epilepsy respond to treatment better than others. Lennox-Gastaut is severe epilepsy which usually manifests itself before the age of 4, and includes several different types of seizures including atonic. Atonic seizures include sudden falls sometimes called drop attacks. Some types of childhood epilepsies become benign or stop entirely during adolescence, but Lennox-Gastaut is usually present for a lifetime. More than 30 percent of this type of epilepsy does not have a recognized cause.

Hope has come in the form of the drug Banzel (rufinamide), which has just been approved for the treatment of Lennox-Gastaut syndrome by the FDA. A four-month clinical trial included patients aged 4 to 30. The patients on the drug, as compared to a placebo group, had 41 percent fewer atonic seizures and 20 percent less seizures of any type, the agency said in a news release.

The warning label on the drug will include the increased risk of suicidal thoughts or behavior. Other side effects include headache, dizziness, fatigue, drowsiness, double vision, nausea, vomiting and problems walking. As with all antiepileptic drugs, the patients who are taking Banzel will receive a patient medication guide that describes the risks.

The drug is manufactured by Eisai Medical Research, Inc. and was approved under the "orphan drug status." The designation is given to a drug intended to treat a disease or condition that affects fewer than 200,000 people in the United States.