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| |  Depakote Cleared by FDA as Treatment for Complex Partial Seizures ABBOTT PARK, Ill., June 24, 1996 -- Abbott Laboratories (NYSE: ABT) announced today that Depakote (divalproex sodium) is now indicated for treatment of complex partial seizures (CPS), a common type of epilepsy. This new indication increases the breadth of seizure coverage provided by the established anti-epilepsy agent. 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. Depakote-treated patients showed significant improvement by reducing seizure frequency. This improvement was established in clinical trials with Depakote as adjunctive or monotherapy conducted with patients 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 with Depakote. 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 treatment. "Depakote is effective in the treatment of complex partial seizures both as a sole treatment and as adjunctive therapy," says Paul Clark, senior vice president, pharmaceutical operations at Abbott Laboratories. "This new indication for Depakote reflects its importance as a first- line treatment for epilepsy." 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 patients receiving valproic acid and its derivatives (including Depakote), 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. The indication of Depakote for complex partial seizures adds to Abbott Laboratories' long-standing commitment to developing new treatments for epilepsy and other neurological conditions. Abbott began its epilepsy research in the 1940s. Abbott Laboratories is a worldwide manufacturer of health care products, employing 50,000 people. 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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