The FDA ( Food and Drug Administration ) has approved once-daily Seroquel XR ( Quetiapine fumarate ) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to Lithium or Divalproex.
Bipolar disorder, also known as manic depressive illness, is a serious psychiatric condition that consists of recurring episodes of depression and mania. Approximately 8 million American adults may be affected by bipolar disorder.
AstraZeneca submitted two separate supplemental new drug applications ( sNDAs ) to the FDA to seek approval for these indications.
The bipolar depression submission was supported by a clinical study of treatment with Seroquel XR compared with placebo in 280 patients diagnosed with bipolar depression.
The primary endpoint was change from baseline in MADRS ( Montgomery-Asberg Depression Rating Scale ) total score compared to placebo at week 8.
In the study, Seroquel XR at 300 mg once-daily was significantly more effective than placebo. The mean change in MADRS total score from baseline to Week 8 was -17.4 for Seroquel XR compared with -11.9 for placebo ( p