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FDA Approves Quetiapine for Maintenance Treatment in Bipolar Disorder
WASHINGTON, DC -- May 14, 2008 -- AstraZeneca announced today that the United States Food and Drug Administration (FDA) has approved quetiapine fumarate (Seroquel) for the maintenance treatment of patients with bipolar I disorder, as adjunct to lithium or divalproex. Quetiapine is approved by the FDA for the treatment of schizophrenia, and is also the only single agent approved by the FDA for the treatment of both depressive and acute manic episodes associated with bipolar disorder.
The FDA approval was based on 2 multicentre, randomised, double-blind, placebo-controlled clinical trials which are part of the clinical trial program known as BOLDER (Bipolar Depression). These 2 studies evaluated quetiapine when used as an adjunct therapy to lithium or divalproex in the maintenance treatment of adults with bipolar I disorder (n = 703, n = 623, respectively). The rigourous study design included a 12- to 36-week stabilisation phase which was followed by up to 2 years of randomised, double-blind treatment (mean duration of quetiapine treatment was 189 and 240 days, respectively).
In both studies, patients with bipolar I disorder whose most recent episode was manic, depressed, or mixed were treated with either quetiapine (flexible dosing between 400 mg and 800 mg per day in divided doses) plus lithium or divalproex, or placebo plus lithium or divalproex. The primary endpoint -- time to recurrence of a depressive, manic, or mixed-mood event -- was significant for quetiapine compared with placebo in both studies.
Pooled study results indicated that patients treated with quetiapine plus lithium or divalproex had a risk reduction of 70% relative to those in the placebo arm for time to recurrence of a mood event (hazard ratio [HR]: 0.30; 95% confidence interval [CI]: 0.24-0.37; P < .001). This reduction in risk was significant for both recurrence of manic episodes (HR: 0.30; 95% CI: 0.22-0.41; P < .001) and recurrence of depressive episodes (HR: 0.30; 95% CI: 0.23-0.40; P < .001). The proportion of patients who relapsed when treated with quetiapine was 19.3% (125/646) versus 50.4% (343/680) of patients on placebo.
Source: AstraZeneca
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