FDA approves Abbott's Depakote extended release formula for bipolar disorder

By E. Janene Geiss

Philadelphia, Dec. 7 - Abbott announced that the U.S. Food and Drug Administration has approved a new indication for Depakote ER (divalproex sodium extended-release tablets) for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.

Depakote ER offers patients the convenience of taking this medication once a day, officials said in a news release.

Compared with Depakote (divalproex sodium delayed-release tablets), officials said Depakote ER taken once a day helps provide more consistent levels of medication in the body.

"Successful treatment for mania depends upon maintaining steady levels of medication in the blood throughout the day," Charles Bowden, professor of psychiatry and pharmacology, department of psychiatry, University of Texas Health Science Center at San Antonio, said in the release.

"Depakote ER produces consistent concentrations of medication throughout a 24-hour period. Depakote has been trusted by psychiatrists for a decade and this once-a-day formulation is important for patients," Bowden added.

The effectiveness of Depakote ER was confirmed in a randomized, double- blind, placebo-controlled parallel group, three-week, multi-center study, officials said.

The primary efficacy measurement was the Mania Rating Scale total score evaluated on day 21 as mean change from baseline to final evaluation on day 21.

Depakote ER was significantly more effective than placebo in the reduction of the Mania Rating Scale total score. It was based in part on studies establishing the effectiveness of Depakote, officials said.

Approximately 2.3 million American adults have bipolar disorder, also known as manic-depressive illness.

Abbott, based in Abbott Park, Ill., is a health care company focused on the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.

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