AstraZeneca’s Seroquel XR (quetiapine fumarate extended-release tablets) has been approved for the treatment of depressive episodes in bipolar disorder, manic and mixed episodes in bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunct therapy to lithium or divalproex.

In a clinical trial of 280 patients, Seroquel XR was significantly more effective than placebo in treating bipolar depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). In a second trial of 316 subjects, Seroquel XR significantly improved the symptoms of bipolar mania or mixed episodes as measured by the Young Mania Rating Scale (YMRS) compared to placebo.

Seroquel XR is already indicated for the treatment of schizophrenia.

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