AstraZeneca seeks approval for new Seroquel indications

AstraZeneca has submitted two supplemental New Drug Applications to the US Food and Drug Administration for the use of Seroquel XR (quetiapine fumarate) in the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes with bipolar disorder.

The bipolar mania submission comes off the back of a clinical study investigating the once-daily extended release tablet compared with placebo.

Its primary endpoint was the change in the Young Mania Rating Scale total score in week three in 316 patients suffering from bipolar disorder.

The bipolar submission is based on a clinical study of Seroquel XR compared to placebo with a primary endpoint of change from baseline in Montgomery Asberg Depression Rating Scale total score after eight weeks in 280 patients with bipolar depression.

Doses of Seroquel XR in both studies were comparable to the FDA-recommended doses of the once-daily treatment in those indications and both trials met their primary endpoints.

Seroquel XR is already approved in eight countries for the maintenance of schizophrenia in adults and it is estimated that more than 25 million patients have been prescribed the drug since its launch in 1997.

Last month, AstraZeneca presented the first data from the clinical development programme of Seroquel XR at the 7th International Forum on Mood and Anxiety Disorders in Budapest.