FRIDAY, Nov. 21 -- A new drug called Banzel (rufinamide) has been approved
as a supplementary treatment for a severe form of epilepsy called
Lennox-Gastaut syndrome, the U.S. Food and Drug Administration announced
Friday.
The approval was based on results of a four-month clinical trial that
included patients ages 4 to 30. Compared to patients who took a placebo,
those who took the drug had 41 percent fewer tonic plus atonic seizures and
20 percent fewer seizures of any type, the agency said in a news
release.
Common side effects included headache, dizziness, fatigue, drowsiness,
double vision, nausea, vomiting, and problems walking.
As with all other antiepileptic drugs, Banzel will carry a warning that it
may increase the risk of suicidal thoughts or behaviors. All patients who
take Banzel must be given a patient medication guide that describes the
risk of suicidal thoughts and behaviors associated with this class of
drugs, the FDA said.
Banzel, manufactured by Eisai Medical Research Inc. of Woodcliff Lake,
N.J., was granted "orphan drug status" by the FDA. This designation is
given to a drug intended to treat a disease or condition that affects fewer
than 200,000 people in the United States.
Lennox-Gastaut syndrome usually begins before age 4 and can be caused by
brain malformations, severe head injury, central nervous system infection
and inherited degenerative or metabolic conditions. No cause can be found
in 30 percent to 35 percent of cases, the FDA said.
Patients with this form of epilepsy may experience periods of frequent
seizures mixed with brief, relatively seizure-free periods. They suffer
from varying types of seizures, including tonic (stiffening of the body,
upward deviation of the eyes, dilation of the pupils, and altered
respiratory patterns), atonic (brief loss of muscle tone and consciousness,
causing abrupt falls), atypical absence (staring spells), and myoclonic
(sudden muscle jerks).
Most children with Lennox-Gastaut syndrome have some degree of impaired
intellectual functioning or information processing, as well as
developmental delays and behavioral issues.
"This approval offers another treatment option for patients who suffer from
these debilitating, severe seizures," Dr. Russell Katz, director of the
division of neurology products in the FDA's Center for Drug Evaluation and
Research, said in the news release.
More information
Epilepsy Ontario has more about Lennox-Gastaut syndrome -
http://www.epilepsyontario.org/client/EO/EOWeb.nsf/web/Lennox-Gastaut+Syndrome
.
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