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FDA Approves AstraZeneca's Seroquel(R) for Maintenance Treatment in Bipolar Disorder
Date:5/14/2008

erved in these trials.

"To date, long-term controlled studies of maintenance therapies have been relatively few and typically focused on either the manic or depressive phase of the illness, but not on both," said Mark Scott, Executive Director, Clinical Development, SEROQUEL. "SEROQUEL is the only single agent to offer proven efficacy in both the manic and depressive episodes in bipolar disorder, and now has demonstrated proven efficacy as an adjunct treatment for the maintenance treatment of bipolar I disorder."

Launched in 1997, SEROQUEL has been prescribed to millions of patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the U.S. for the treatment of bipolar depression.

IMPORTANT SAFETY INFORMATION FOR SEROQUEL

SEROQUEL is indicated for the treatment of depressive episodes in bipolar disorder; acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; maintenance treatment of bipolar I disorder, as adjunct to lithium or divalproex; and schizophrenia. Patients should be periodically reassessed to determine the need for treatment beyond the acute response.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death, compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL is not approved for the treatment of patients with dementia-related psychosis. (See Boxed Warning.)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Patients of all ages started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation an
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SOURCE AstraZeneca
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