Banzel Approved for Lennox-Gastaut Syndrome
FRIDAY, Nov. 21 -- Banzel (rufinamide) has been approved by the U.S. Food and Drug Administration to treat seizures associated with Lennox-Gastaut syndrome, a severe form of epilepsy.
The disease usually begins before a child turns 4. Common triggers include a malformed brain, severe head injury, an infection of the central nervous system, or certain inherited conditions. In about one-third of cases, no cause can be found.
In addition to seizures, most children with the disease have impaired intellect, developmental delays and behavioral problems, the agency said in a statement posted on its Web site.
In clinical studies of patients aged 4 to 30, those taking Banzel had a 41 percent reduction in certain types of seizure, and a 20 percent reduction in total seizures, compared to a placebo. The most common side effects included headache, dizziness, fatigue, impaired walking, double-vision and nausea.
The drug's label will include a warning that Banzel could increase the user's risk of suicidal thoughts or tendencies, and that patients should be monitored closely for worsening signs of depression or suicidal behavior, the FDA said.
Banzel is produced by Eisai Medical Research Inc., of Woodcliff Lake, N.J.
The FDA has more about this drug's approval.
Posted: November 2008