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AZ Submits sNDAs for Seroquel XR

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By: Tim Wright

Editor-in-Chief, Contract Pharma

AstraZeneca submitted two sNDAs to the FDA for once-daily Seroquel XR Extended-Release Tablets in the following indications: treatment of manic episodes associated with bipolar disorder and treatment of depressive episodes associated with bipolar disorder.
   
The bipolar mania submission is based on a study of once-daily treatment with Seroquel XR, compared to placebo, with a primary endpoint of change in YMRS (Young Mania Rating Scale) week three, in 316 patients suffering from bipolar mania. The bipolar depression submission is supported by a 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) after 8 weeks of treatment, in 280 patients diagnosed with bipolar depression.
   
Both studies met their primary endpoint and doses of the drug administered in both studies were comparable to the FDA-approved doses for Seroquel (quetiapine fumarate) immediate release tablets in the two indications.  
   
Seroquel XR is currently approved in eight countries including the U.S., Canada and The Netherlands, for the acute and maintenance treatment of schizophrenia in adults.

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