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news.AstraZeneca has received the FDA's approval for once-daily Seroquel extended-release tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.
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Seroquel extended-release (XR) is said to be the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder.
AstraZeneca submitted two separate supplemental new drug applications to the FDA to seek approval for these indications. The bipolar depression submission was supported by a clinical study of treatment with Seroquel XR compared with placebo in 280 patients diagnosed with bipolar depression. The primary endpoint was change from baseline in Montgomery-Asberg Depression Rating Scale total score compared to placebo at week eight.
The bipolar mania submission was based on a clinical study of treatment with Seroquel XR compared with placebo in 316 patients with bipolar mania or mixed episodes with or without psychotic features. The primary endpoint was change from baseline in Young Mania Rating Scale total score compared to placebo at week three.
Lisa Schoenberg, vice president of specialty care at AstraZeneca, said: “These new indications for Seroquel XR mark an important milestone in the treatment of bipolar disorder. In addition to today’s approval for the treatment of both the depressive and manic symptoms associated with this condition, Seroquel XR is now also approved as a long-term treatment option for bipolar I disorder.”