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| |  Depakote Now Indicated for Prevention of Migraine Headaches ABBOTT PARK, Ill., -- March 28, 1996 -- Abbott Laboratories' Depakote (divalproex sodium) tablets have been cleared by the U.S. Food and Drug Administration for the prevention of migraine headaches. The entry of Depakote into the marketplace represents a new prophylactic treatment option for migraine headache sufferers. "Some patients do not respond to medication once a migraine attack is under way, or they may experience migraine headaches more than two times a month. These individuals may benefit from preventive treatment with divalproex sodium," says Andre Pernet, Ph.D., vice president, pharmaceutical research and development, Abbott Laboratories. "In contrast to acute therapies, this medication is taken daily to reduce the frequency of migraine headaches." Depakote has been marketed in the United States since 1983. "Divalproex sodium is an important advance in the prophylactic treatment of migraine," says Stephen Silberstein, M.D., co-director of the Comprehensive Headache Center at the Germantown Hospital in Philadelphia, Pa. "Patients who are unable to find relief with other agents may benefit from therapy with Depakote." Approximately 23 million Americans suffer from migraine headaches. Of those, approximately 11 million suffer moderate to severe migraines that are disabling. Migraine headaches are characterized by intense, recurrent pain on one or both sides of the head, and usually are accompanied by one or more concurrent symptoms, including nausea, vomiting, and an increased sensitivity to noise and/or bright light. Treatment for migraine may involve acute therapies, which are taken by the patient at the onset of a migraine, or preventive treatments, which may involve daily drug therapy. The results of two double-blind, placebo-controlled, multicenter trials established the efficacy of Depakote in reducing the incidence of migraine headaches. Both studies consisted of a four-week initial phase, during which patients were monitored to determine migraine headache frequency, and a 12-week treatment phase. Almost half of Depakote-treated patients showed a reduction in migraine frequency. Depakote was generally well tolerated in the two clinical trials. Most frequent adverse events reported by patients receiving Depakote were nausea, dyspepsia, diarrhea, vomiting, weakness and fatigue, sleepiness and dizziness. Events leading to discontinuation included hair loss, nausea, vomiting, weight gain and tremor. Other safety considerations include hepatic failure, which has resulted in fatalities in patients receiving valproic acid and its derivatives, usually in the first six months of treatment. Valproic acid can produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Divalproex sodium is a derivative of valproic acid. The use of Depakote tablets for migraine prophylaxis in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the fetus. Patient information regarding the use of Depakote in migraine patients is available. Abbott Laboratories is a worldwide manufacturer of health care products, employing 50,000 people. The company researches, develops and markets pharmaceutical, diagnostic, nutritional and hospital products. In 1995, the company's sales and net earnings were $10.0 billion and $1.7 billion, respectively, with earnings per share of $2.12.
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