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SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia
Date:11/16/2007

WILMINGTON, Del., Nov. 16 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets for maintenance treatment of schizophrenia in adult patients. On May 17, 2007, the FDA approved SEROQUEL XR for the acute treatment of schizophrenia in adult patients.

Schizophrenia patients experience high rates of symptom relapse, and as a result, there is an important need for long-term treatment options for schizophrenia to help reduce the risk of the recurrence of acute psychotic episodes. (1,2)

In the clinical trial supporting this approval, patients with schizophrenia who were treated with SEROQUEL XR experienced a significantly longer time to relapse, compared with patients receiving placebo. Patients receiving SEROQUEL XR demonstrated an 84% reduction in the relative risk of relapse (hazard ratio 0.16; p<0.0001). Results showed the estimated risk of relapse after six months was 14.3% in the SEROQUEL XR group versus 68.2% in the placebo group (p<0.0001). Differences in relapse rate between active treatment and placebo were large enough to require the study to be stopped early. The complete results of the clinical trial appear in the November issue of the journal Psychiatry 2007.(3)

"Today's FDA approval helps address the need for longer-term treatment options for patients with schizophrenia," said Mark Scott, Ph.D., Executive Director for Development, AstraZeneca. "The clinical trial results provided compelling evidence for reducing the risk of relapse when these patients are treated with SEROQUEL XR."

Schizophrenia is a serious brain disorder with symptoms including distorted perceptions of reality, hallucinations and delusions, illogical thinking, and flat or blunted emotions, affecting over 2 million American adults -- about 1% of the population 18 years and older.(4,5)

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SOURCE AstraZeneca
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