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FDA Approves Banzel (rufinamide) Oral Suspension, 40 mg/mL

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Mar 4, 2011 - Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Banzel (rufinamide) Oral Suspension, 40 mg/mL, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. The oral suspension formulation is bioequivalent to the currently marketed Banzel tablet formulation on a milligram per milligram basis and will be available for prescription use by late March 2011.

"This new formulation provides an option for patients who may prefer a liquid or find it difficult to take the medication in tablet form," said Lonnel Coats, president and CEO of Eisai Inc. "The development of an oral suspension formulation further exemplifies Eisai's human health care (hhc) mission of keeping patients' needs at the forefront of all that we do."

About Lennox-Gastaut Syndrome

Lennox-Gastaut syndrome (LGS) is a rare form of epilepsy that affects 1-4% of children with epilepsy. The age of onset is between 1 and 8 years, with peak at 3 to 5 years. LGS affects an estimated 1 in 50,000 to 1 in 100,000 children.

LGS is characterized by a clinical triad of a slow spike-and-wave pattern on an EEG, impairment of cognitive function and multiple types of seizures, including tonic (muscle stiffening), atypical absence (staring) and atonic (loss of muscle tone) seizures being the most common.

About Banzel

Banzel (rufinamide) is an anti-epileptic drug indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. Banzel is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (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 is available in 200 and 400 mg tablets for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. Banzel was approved by the FDA on November 14, 2008.

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.

For Full Prescribing Information and a Medication Guide, please visit www.banzel.com.

About Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. Eisai employs approximately 11,000 employees worldwide.

Posted: March 2011

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Banzel (rufinamide) FDA Approval History

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