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AZ Seeks sNDA for Bipolar Treatment
Posted on 2005-12-30 15:27:00
AstraZeneca today announced that it has submitted a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) to seek approval for a new indication for Seroquel (quetiapine fumarate) for the treatment of patients with depressive episodes associated with bipolar disorder. Seroquel is currently approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia.
"AstraZeneca is dedicated to improving patients' lives and developing new treatments for mental illness," said Wayne Macfadden, MD, US Medical Director for Seroquel. "This sNDA submission is an important milestone in the history of Seroquel. 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."
The sNDA submission is based on results from the clinical trial program known as BOLDER (BipOLar DEpRession), which comprises two studies: BOLDER I and BOLDER II. Both studies were double-blind, placebo-controlled trials of outpatients (N=1,045) with bipolar I or II disorder. Patients were randomized to receive eight weeks of treatment with fixed doses of Seroquel (300 mg or 600 mg) or placebo administered once daily. 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.
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