Anglo-Swedish drug major AstraZeneca says that the results of a clinical trial of its drug Seroquel (quetiapine fumarate) indicate that the agent has potential as a monotherapy for major depressive episodes in patients with bipolar disorder. The findings, which are published in the December issue of the Journal of Clinical Pharmacology, are derived from the BOLDER II study.
Michael Thase, medical director of the University of Pittsburgh Medical Center in Pennsylvania, USA, and the study's principal investigator, said: "patients treated with Seroquel in BOLDER II saw an improvement in their depressive symptoms within one week and more than half by week eight."
AstraZeneca said that, as a result of positive BOLDER II data, which build on the findings of the BOLDER I program that were published in 2005, the product is the first and only medication of its kind approved by the US Food and Drug Administration to treat both the depressive and manic episodes associated with bipolar disorder.
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