FDA Accepts BANZEL(R) (Rufinamide) Oral Suspension NDA For Review

Main Category: Epilepsy
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 21 Jul 2010 - 0:00 PDT

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Eisai Inc. (Headquarters: Woodcliff Lake, NJ; President and CEO: Lonnel Coats), a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo; President and CEO: Haruo Naito) announced that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's NDA for BANZEL® (rufinamide) Oral Suspension (40 mg/mL). The proposed indication is for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older and adults. The application is based on data from a study designed to demonstrate the bioequivalence of the oral suspension formulation to the currently marketed BANZEL tablet formulation (400 mg).

Acceptance of the NDA indicates that the FDA has found the company's submission to be sufficiently complete to review. The NDA was submitted to FDA on April 30, 2010.

The BANZEL oral suspension was developed to provide a new option for children over four years and adults who have trouble swallowing tablets.

About Lennox-Gastaut Syndrome (LGS)

LGS is a rare form of epilepsy that affects 1 to 4 percent of all children with epilepsy. Children and adults living with LGS experience frequent seizures of multiple types that are difficult to control and they can be developmentally delayed.

About BANZEL®

BANZEL is a triazole derivative that is structurally unrelated to currently marketed AEDs. The clinical significance of this structural difference has not been established. It is believed to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures. BANZEL tablets (200 and 400 mg) are FDA approved for the adjunctive treatment of seizures associated with LGS in children four years and older and adults.

BANZEL® Important Safety Information

There are risks associated with the use of BANZEL that you should know about. We encourage you to talk to your healthcare provider about these risks.

-- Patients with a history of Familial Short QT syndrome should not be treated with BANZEL. Talk to your healthcare provider if you are unsure if this affects you or your loved one. BANZEL has been shown to reduce the QT interval. Caution should be used when administering BANZEL with other drugs that shorten the QT interval.

-- All medications to treat seizures, including BANZEL, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you or your loved one experiences new or worsening symptoms of depression, unusual changes in mood or behavior, thoughts or actions about suicide or self-harm, aggression, agitation, anger, anxiety, or irritability.

-- Use of BANZEL has been associated with side effects such as sleepiness or feeling tired, difficulty with coordination, dizziness, and problems with walking or movement.

- Alcohol, in combination with BANZEL, may increase or worsen these side effects.

-- Call your healthcare provider if you or your loved one experiences a rash. This can be a sign of a more serious condition, such as multi-organ hypersensitivity reaction.

-- You or your loved one should take BANZEL only as prescribed. Do not stop taking BANZEL without first talking to your healthcare provider. Stopping BANZEL suddenly can cause serious problems.

-- Tell your healthcare provider about all the medications you or your loved one takes, including prescription and non-prescription medications, vitamins, and herbal supplements. Using BANZEL with certain medications can affect each other, causing side effects.

-- In studies, the most commonly observed (≥10%) side effects with BANZEL vs placebo (sugar pill with no medicine in it), respectively, were headache (25% vs 20%), dizziness (17% vs 10%), feeling tired (15% vs 9%), sleepiness (13% vs 9%), and nausea (11% vs 7%). Most of these side effects were mild to moderate in severity and typically went away in a short amount of time.

Medication Guide

Source:
Eisai Inc.

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