Banzel- uses and side effects

BANZEL™ (rufinamide)
Potential health benefits 2008

ALL RIGHTS RESERVED ZHION 2008. DO NOT TRANSFER THIS ARTICLE TO OTHER
WEBSITES OR BLOGS. CONSULT WITH YOUR DOCTOR FOR ANY QUESTION OR BEFORE
TAKING ANY SUPPLEMENT OR MEDICINE. THIS ARTICLE IS FOR YOUR REFERENCE ONLY.

APPROVAL / USE / INDICATIONS

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.

Approximately 300,000 children under the age of 14 in the U.S. have epilepsy and
LGS accounts for 1 to 4 percent. Children are usually between 1 and 5 years old
when symptoms start. About 3 to 7 per cent of LGS patients die within an average
of under 10 years. [3]

Symptoms include many types of seizures, the common ones being tonic or muscle
stiffening, atonic such as loss of muscle tone or drop attacks, and absence or
staring seizures. Drop attacks are seizures that cause the patient to lose
consciousness and fall to the ground, they are a main cause of injury in LGS
patients. Less common seizures include tonic-clonic (grand mal) and myoclonic
(sudden muscle jerks). [3]

STRENGTHS

MECHANISM

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 SIDE EFFECTS

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.

SAFETY ISSUES / CONTRAINDICATION

BANZEL is contraindicated in patients with Familial Short QT syndrome. These
patients should not be treated with BANZEL. Caution should be used when
administering BANZEL with other drugs that shorten the QT interval. [2]

MANUFACTURER

BANZEL™ is a trademark of Novartis Pharma AG, used under license.
Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc., Woodcliff Lake, NJ 07677 [2]

SALES/MARKET

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.

Reference
[1] FDA Approves New Drug to Treat Severe Form of Epilepsy FDA NEWS
November 20, 2008 [2] www.banzel.com 2008 [3] Severe Epilepsy Drug Banzel Wins
FDA Approval Medical News Today .com 24 Nov 2008