AstraZeneca announced the US Food and Drug Administration (FDA) has approved Seroquel as a monotherapy and adjunct therapy with lithium or divalproex, for the short-term treatment of acute manic episodes associated with bipolar I disorder. The approval is based on results of several registration trials for bipolar disorder, which showed Seroquel to be well-tolerated and effective in the treatment of manic episodes - excited mental states seen in bipolar disorder that are characterized by impulsive behaviour, racing thoughts, pressured speech, and decreased need for sleep.

Patients taking Seroquel in the registration trials, either as a monotherapy or as an adjunct to divalproex or lithium, showed improvement of their manic symptoms within the first week of treatment. The improvement was statistically superior to that of placebo or placebo plus lithium or divalproex as measured by the Young Mania Rating Scale (YMRS), a common psychiatric measurement tool.

"The new indication for Seroquel represents another treatment option for the millions of people who suffer from bipolar mania," said Dr Trisha Suppes, Bipolar Disorder Research Programme director, University of Texas Southwestern Medical Center. "While results for individual patients may vary, Seroquel was well tolerated in clinical trials and represents a new option for the treatment of acute mania associated with bipolar disorder."

Seroquel, which has been approved for the treatment of schizophrenia in adults since 1997, is the fastest growing leading psychotropic medication on the market in the United States. Since its initial approval for schizophrenia, there have been approximately 21.5 million prescriptions written for Seroquel, for more than 5.3 million patients in the United States.

Bipolar disorder, which affects about 2.3 million American adults every year, consists of recurring episodes of mania and depression. Without appropriate treatment, patients with this disorder usually suffer for a lifetime with periods of wellness and functioning punctuated by severe episodes of illness. Both men and women are equally at risk for this illness, which most often emerges in adolescence or young adulthood and recurs throughout life.