The drug is currently approved for the treatment of acute manic episodes associated with bipolar disorder and the treatment of schizophrenia. Bipolar disorder consists of recurring episodes of mania and depression.
“If Seroquel receives approval from the FDA to treat bipolar depression, it would be the only single agent indicated to treat both the depressive and manic episodes associated with bipolar disorder,” said Dr Wayne Macfadden, US medical director for Seroquel.
The submission is based on results from two clinical studies. In both studies, patients receiving Seroquel, as compared to those receiving placebo, showed a statistically significant decrease in depression scores at week one, and scores continued to decrease throughout the eight-week study. More than half of the Seroquel treated patients in each trial met the criteria for remission.