AstraZeneca has announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.
The bipolar mania submission is based on a clinical study of once-daily treatment with SEROQUEL XR, 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 XR, compared to placebo, with a primary endpoint of change from baseline in MADRS (Montgomery Asberg Depression Rating Scale) total score after eight weeks of treatment, in 280 patients diagnosed with bipolar depression.
Doses of SEROQUEL XR administered in both the bipolar mania (400 mg to 800 mg/day) and bipolar depression (300 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 and it is expected that they will be presented at major scientific congresses in 2008.
SEROQUEL XR is currently approved in eight countries including US, Canada and The Netherlands, for the acute and maintenance treatment of schizophrenia in adults.