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FDA Approves Once-Daily Depakote ER (Divalproex Sodium) For Complex Partial And Complex Absence Seizures Once-a-Day Formulation of Trusted Epilepsy Drug Will Offer Patient Convenience for Complex Partial or Absence Seizures ABBOTT PARK, IL -- December 23, 2002 -- Abbott Laboratories (NYSE: ABT) announced that the U.S. Food and Drug Administration (FDA) has approved Depakote® ER (divalproex sodium extended-release) tablets for sole and adjunctive therapy to treat complex partial seizures and simple and complex absence seizures in adults with epilepsy. Depakote ER is the once- daily formulation of Depakote® (divalproex sodium delayed release) tablets, which has been a leading medication for the treatment of epilepsy since its approval in 1983. Depakote ER was approved for migraine prevention in 2000. "The Depakote ER once-daily formulation will provide additional dosing convenience for treating epilepsy," said Basim Uthman, M.D., associate professor of neurology, University of Florida College of Medicine and Malcom Randall Department of Veterans Affairs Medical Center. "In my clinical experience, flexible dosing of epilepsy medications has helped simplify regimens for patients." Depakote ER adds another convenient option to the versatile family of Depakote products for the treatment of complex partial and absence seizures, which includes Depakote, Depakote® Sprinkle Capsules (divalproex sodium coated particles in capsules), and Depacon® (valproate sodium injection), an intravenous alternative. The once-daily Depakote ER formulation will be available in both the 250 mg and 500 mg tablets in pharmacies. "This approval further enhances Abbott's 50-year commitment in the development of significant epilepsy treatments," said John Leonard, M.D., vice president, Global Pharmaceutical Development, Abbott Laboratories. "Our commitment to Depakote is far reaching -- for the past 20 years, we have continued to introduce new indications and formulations for Depakote, which have provided more treatment options for patients with neurological and psychological disorders." More than two million Americans have some form of epilepsy, and 125,000 new cases of epilepsy are reported each year. Epilepsy is a chronic neurological condition that can result in periodic disturbances in the normal electrical functions of the brain, resulting in seizures, which are caused by unusually intense and intermittent electrical energy in the brain. Seizures can impact a person's consciousness, body movements or sensations for short periods of time. Depakote ER Clinical Study Results Depakote ER was studied in two clinical trials, one in healthy adult subjects (n=35) and one in adult patients with epilepsy (n=64). In the trial with healthy patients, once-daily Depakote ER was dosed 14 to 20 percent higher than the Depakote twice-daily dose (BID). In the trial with adult patients with epilepsy, once-daily Depakote ER was dosed 8 to 20 percent higher than Depakote dosed three times a day (TID). These Depakote ER once-daily dosing regimens were shown to be equivalent to Depakote BID and TID dosing regimens. This was determined by measuring the level of the drug in the blood over a period of time (plasma concentration-time curve). Once-daily dosing will simplify the dosing regimen for patients, and therefore offer patients a more convenient option. Important Product Safety information Depakote, Depakote ER (in adults), Depakote Sprinkle Capsules, and Depacon are indicated for the treatment of complex partial seizures and simple and complex absence seizures. Depacon is indicated as an intravenous alternative in patients for whom oral administration of valproate products is temporarily not feasible. Depakote and Depakote ER are also indicated for the prevention of migraine headaches in adults. Valproate products should not be administered to patients with hepatic disease or significant hepatic dysfunction. Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives, usually during the first six months of treatment. Valproate may produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Benefits of using Depakote and Depakote ER in migraine treatment should be weighed against risk of injury to the fetus in women of childbearing potential. Cases of life-threatening pancreatitis, some rapidly progressing to death, have been reported in both adults and children receiving valproate. Valproate is contraindicated in patients with known urea cycle disorders (UCD), a group of uncommon genetic abnormalities, due to reports of sometimes-fatal cases of hyperammonemic encephalopathy. The frequency of adverse effects, particularly elevated liver enzymes and thrombocytopenia, may be dose-related. In a clinical trial of valproate in elderly patients with dementia, some patients taking valproate experienced somnolence, sometimes requiring discontinuation. The safety and effectiveness of Depakote and Depakote ER for the prevention of migraine patients over 65 years have not been established. About Abbott Laboratories Abbott Laboratories is committed to the research and development of treatments for neurological disorders. Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's website at http://www.abbott.com . Please see full prescribing information for Depakote, Depakote ER, Depakote Sprinkle Capsules and Depacon at http://www.depakote.com and http://www.depacon.com . SOURCE: Abbott Laboratories E-mail this page to a friend or colleague! To print, use this version