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

Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research said, "This approval offers another treatment option for patients who suffer from these debilitating, severe seizures."

The approval has come after the results of a four month long clinical trial conducted on patients between ages 4 to 30. The researchers found that patients who took the drug had 41 % fewer tonic plus atonic seizures and 20 % fewer seizures of any type, as compared to the patients who were given a placebo.

Lennox-Gastaut syndrome is the more severe form of epilepsy and it usually sets in before the age of 4. It can be due to brain malformations, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions though in 30-35 % of cases, no cause can be found.

The drug Banzel is manufactured by Eisai Medical Research Inc., Woodcliff Lake, N.J. The drug was granted "orphan drug status" by the FDA which means the drug is intended to treat a disease or condition that affects fewer than 200,000 people in the United States.

Banzel, like all other antiepileptic drugs will carry a warning about the risk of increased suicidal thoughts or behaviors. All those on the drug should be monitored for signs of depression, suicidal thoughts or behavior, and unusual changes in mood or behavior which are commonly associated with this class of drugs, the FDA said. Common side effects of the drug are headache, dizziness, fatigue, drowsiness, double vision, nausea, vomiting, and problems walking.