Clinical Trials Resource Center
FDA Approved Drugs » 1996
Medical Areas: Neurology | Family Medicine | Genetic Disease
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Abbott Laboratories
Approval Status: Approved June 1996
Treatment Area: epilepsy
Depakote has been approved for the treatment of complex partial
seizures (CPS), a common type of epilepsy. This is a new indication
for Depakote, which has already been approved for the treatment of
migraine headaches. The new indication for treatment of CPS
includes using Depakote as a sole agent (monotherapy) or as
adjunctive therapy for use with other anti-epilepsy drugs. Both
Depakote tablets and sprinkle capsules can be used for
Depakote-treated subjects showed significant improvement by
reducing seizure frequency. This improvement was established in
clinical trials with Depakote as adjunctive or monotherapy
conducted with subjects who continued to experience seizures while
taking their current epilepsy medication. Seizure frequency was
calculated to reflect the median number of seizures during an
eight-week measurement period versus an eight-week treatment period
In clinical trials, Depakote was generally well tolerated. Most
adverse events were mild to moderate in severity. Common adverse
events were nausea, tremor, somnolence, vomiting, asthenia,
abdominal pain, and anorexia. Other important safety considerations
include the possibility of hepatic failure, which has resulted in
fatalities in subjects receiving valproic acid and its derivatives,
usually occurring during the first six months of treatment.
Valproic acid may produce teratogenic effects in the offspring of
women receiving the drug during pregnancy, Thrombocytopenia, an
abnormally low number of platelets in the blood, has also been
associated with Depakote use. The incidence of thrombocytopenia
appears to be dose related.
Approximately 2.5 million people in the United States have some
form of epilepsy and an estimated 125,000 new cases are diagnosed
each year. Depakote has been marketed in the United States since
1983 as a treatment for simple and complex absence seizures.
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