A new drug called Banzel (rufinamide) has been approved by the U.S. Food and Drug Administration to treat a severe form of epilepsy, called Lennox-Gastaut syndrome, also known as Lennox sydrome. LGS is a difficult-to-treat form of childhood-onset epilepsy that most often appears between the second and sixth year of life. The disease is characterized by frequent seizures and it is often accompanied by impaired intellectual functioning and behaviour problems. The disease could be caused by brain malformations, severe head injury, central nervous system infection and inheritive or metabolic conditions.

“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 in a statement. The FDA said that the patients who take Banzel will have to be given a medication guidelines that describes the exact suicidal thoughts and behaviours linked to these types of drugs. Patients should be closely monitored for worsening signs of depression and suicidal thoughts, the FDA said.

Clinical trials of patients aged 4 to 30 have shown that among those taking Banzel there had been a 41 percent reduction in certain types of seizures, and a 20 percent reduction in total seizures, compared to those that took a placebo. The most common side effects included headache, dizziness, fatigue, impaired walking, double-vision and nausea.

Banzel is manufactured by Eisai Medical Research Inc., Woodcliff Lake, N.J.

It is estimated that 5% of children with epilepsy have LGS. It is more common in males than in females. West syndrome is seen in 20% of patients before (symptomatic) LGS.