Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Neurology | Family Medicine | Genetic Disease
View By:YearCompanyConditionsTherapeutic AreasDrug Names
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Ortho-McNeil Pharmaceutical
Approval Status: Approved January 1997
Treatment Area: partial onset seizures
Topamax (topiramate) has been approved as a new antiepileptic
drug proven to reduce the frequency of seizures, particularly among
patients who are not controlled by other antiepileptic drugs
(AEDs). Topamax is indicated as adjunctive therapy for partial
onset seizures, the most common seizure type, in adults.
Therapy should be initiated at a low dose of 50 mg per day and
gradually increased to an effective dose. The recommended daily
dose is 400 mg per day in two divided doses.
Topamax has been studied in more than 2,000 epilepsy subjects
worldwide. Five placebo-controlled, double blind clinical trials
with Topamax demonstrated consistent results in reducing the
frequency of seizures. In one trial with 181 subjects, seizure
frequency was reduced by at least half in 44 percent (vs. 18
percent for placebo) and at least 75 percent in 22 percent of
subjects (vs. 18 percent for placebo) taking the recommended 400 mg
per day. Once stabilized on Topamax, four percent of subjects were
seizure free throughout the trial period; no subjects on placebo
were free of seizures during the same trial period. Patients
selected for the trial were being treated with traditional AEDs;
their average seizure frequency was approximately 11 per month at
the time they entered the trial.
Clinical trials indicate that Topamax is generally well
tolerated by subjects and has few clinically significant
interactions with traditional AEDs. The most frequently reported
side effects were related to the central nervous system, which is
common for this class of drugs, such as difficulty concentrating,
drowsiness, dizziness and coordination problems. Most side effects
were mild to moderate in severity and usually disappeared over
time. There was a 1.5 percent incidence of kidney stones; nearly 80
percent of patients experiencing stones continued Topamax
Approximately 30 percent of people with epilepsy in the United
States--at least 650,000 patients--continue to experience seizures
despite treatment with currently available medications.
Epilepsy is a chronic condition characterized by recurrent,
unprovoked seizures, or electrical disturbances in the brain that
can alter a patient’s consciousness, movement or behaviors.
Seizures are characterized as either partial or generalized,
depending on where they originate in the brain.