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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
November 20, 2008

Media Inquiries:
Sandy Walsh, 301-827-3418
Consumer Inquiries:
888-INFO-FDA


FDA Approves New Drug to Treat Severe Form of Epilepsy

The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome.

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

Lennox-Gastaut syndrome is a severe form of epilepsy that usually begins before 4 years of age, and can be caused by brain malformations, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions. In 30-35 percent of cases, no cause can be found. Patients may have periods of frequent seizures mixed with brief, relatively seizure-free periods; and 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 experience some degree of impaired intellectual functioning or information processing, along with developmental delays and behavioral disturbances.

In a single four-month clinical trial studying patients 4 to 30 years old, patients taking Banzel had improved seizure control when compared to those taking placebo. The observed effect was approximately a 41 percent reduction of tonic plus atonic seizure frequency over placebo and 20 percent reduction of total seizure frequency over placebo. In addition, overall improvement was reported as measured by a parent/guardian evaluation.

Common adverse reactions reported by patients using Banzel in clinical trials included headache, dizziness, fatigue, drowsiness, gait disturbance, double-vision, nausea and vomiting. Banzel's labeling will include a warning that antiepileptic drugs increase the risk of suicidal thoughts or behaviors in patients taking the drug for any indication. Patients taking antiepileptic drugs should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and unusual changes in mood or behavior. This warning is based on the results of analyses performed by the FDA on nearly 200 controlled clinical trials with 11 FDA-approved antiepileptic drugs. Banzel was not included in these analyses, but the results are considered to apply to all chronically administered antiepileptic drugs, including Banzel. As discussed at a July 2008 public advisory committee meeting, the FDA is working with manufacturers of all antiepileptic drugs to include similar warning statements in prescribing information. The FDA is requiring that a patient Medication Guide be given to patients and caregivers when Banzel is dispensed. The Medication Guide will describe the risk of suicidal thoughts and behavior associated with the class of antiepileptic drugs.

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

Banzel was granted orphan drug designation by the FDA. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects fewer than 200,000 people in the United States. This designation can also be extended to drugs for diseases or conditions that affect a larger number of patients if there is no reasonable expectation that the cost of developing such medications and making them available will be recovered from sales.

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