| BANZEL™ (rufinamide) Potential health benefits 2008 |
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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
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