Abbott's Depakote - divalproex sodium - Surpasses Lithium as the Most-Prescribed Drug for Treating Mania.

ABBOTT PARK, Ill.--(BUSINESS WIRE)--June 1, 1998--

Prescribing Trend Signals Shift Among Psychiatrists

Abbott Laboratories' Depakote(R) (divalproex sodium) has surpassed lithium, the long-standing market leader, to become the most-prescribed agent by psychiatrists for treating manic episodes associated with bipolar disorder, also known as manic depression. Lithium was the only FDA-approved drug for mania until Depakote was approved in May, 1995.

"The success of Depakote is excellent news for patients with mania associated with bipolar disorder and their families," says Charles Bowden, MD, Chief, Department of Psychiatry, University of Texas, San Antonio. "Depakote has provided a much-needed first-line treatment option for patients suffering from this devastating disease."

More than two million Americans have bipolar disorder, a chronic disease involving severe mood swings consisting of cycles of mania and depression. A manic episode is a distinct period of abnormally and persistently elevated, expansive or irritable mood. Typical symptoms of mania include pressure of speech (more talkative than usual or pressure to keep talking), motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness and possible hostility.

The personal impact of the disease can be devastating. It can result in job loss, alienation of friends and family, and reckless behavior, including excessive spending and promiscuity, and can require hospitalization to prevent harm to oneself or to others.

Two-thirds of all people with bipolar disorder are not properly diagnosed or treated. When properly diagnosed, people with bipolar disorder can be successfully treated with medication.

"Until the approval of Depakote three years ago, we had just one FDA-approved treatment option for mania in bipolar disorder," says Paul Keck, Jr., MD, Professor of Psychiatry and Pharmacology, University of Cincinnati College of Medicine. "Mania presents in several different ways, and Depakote is effective in many patients."

"We're pleased that Depakote has become the market leader for new prescriptions by psychiatrists in treating mania in bipolar disorder," says Ed Fiorentino, vice president, pharmaceutical sales and marketing. "This is certainly a treatable illness and we hope that Depakote will continue to help patients."

In 21-day clinical trials, vomiting (12%) was the only event that was reported by significantly more patients receiving divalproex sodium compared to placebo (3%). Other common adverse events are nausea (22% vs. 15% for placebo), somnolence (19% vs. 12% for placebo) and dizziness (12% vs. 4% for placebo). The rate of discontinuation due to intolerance was not statistically different between placebo, Depakote or the active control.

Depakote 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.

According to published and unpublished reports, valproic acid may produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Divalproex sodium is a derivative of valproic acid.

Although there are no efficacy data that specifically address longer-term antimanic treatment with Depakote, the safety of Depakote in long-term use is supported by data from record reviews involving approximately 360 patients treated with Depakote for greater than three months.

Depakote is a versatile medication. Since its approval in 1983, several indications have been received, making Depakote a valued option to physicians and patients.

Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 54,000 people and markets its products in more than 130 countries. Abbott news releases and other information are available on the company's web site at http://www.abbott.com, and for additional information on Depakote, see www.Rxabbott.com.

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