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news.AstraZeneca has submitted two separate supplemental new drug applications to the FDA for once-daily Seroquel extended-release tablets to seek approval for the treatment of manic and depressive episodes associated with bipolar disorder.
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The bipolar mania submission is based on a clinical study of once-daily treatment with Seroquel, compared to placebo, with a primary endpoint of change in YMRS (Young Mania Rating Scale) total score (week 3), in 316 patients suffering from bipolar mania. The bipolar depression submission is supported by a clinical study of once-daily treatment with Seroquel, compared to placebo, with a primary endpoint of change from baseline in MADRS (Montgomery Asberg Depression Rating Scale) total score after 8 weeks of treatment, in 280 patients diagnosed with bipolar depression.
Doses of Seroquel administered in both the bipolar mania (400mg to 800mg/day) and bipolar depression (30 mg/day) studies were comparable to the FDA-approved recommended doses for Seroquel (quetiapine fumarate) immediate release tablets in those indications. Both studies met their primary endpoint.
Seroquel is currently approved in 8 countries including the US, Canada and the Netherlands, for acute and maintenance treatment of schizophrenia in adults.