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WILMINGTON, Del., May 22, 2007 /PRNewswire-FirstCall/ -- AstraZeneca today announced that two analyses from a large-scale study that investigated the efficacy of SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients, were presented today at the annual meeting of the American Psychiatric Association (APA). These analyses from the clinical trial data for SEROQUEL XR showed that it was effective versus placebo in patients with an acute exacerbation of symptoms of schizophrenia.(1,2)
On May 17, 2007, the U.S. Food and Drug Administration (FDA) approved SEROQUEL XR for the treatment of schizophrenia in adult patients.
"Both analyses show that SEROQUEL XR was superior to placebo, demonstrating it is another viable treatment option for schizophrenia," said Charles Schulz, MD, Professor and Head, Department of Psychiatry, University of Minnesota Medical School. "These analyses are significant because SEROQUEL XR may provide greater convenience and simplicity in patient treatment plans."
About large-scale study: Study 132
This six-week, double-blind, randomized, placebo-controlled study investigated the efficacy and safety of once-daily SEROQUEL XR. In this study, 588 patients with acute schizophrenia were randomized to receive either SEROQUEL XR at 400, 600, or 800 mg/day, the immediate release formulation of SEROQUEL(R) (quetiapine fumarate) at 400 mg/day (200 mg twice-daily), or placebo. The primary endpoint was assessed using the Positive and Negative Syndrome Scale (PANSS)(+).(1,2)
In the study, SEROQUEL XR was generally well-tolerated. SEROQUEL
XR was administered once-daily at fixed doses, with dose escalation
conducted over the initial three days (Day 1 = 300mg, Day 2 = 400
or 600mg, and Day 3=400, 600 or 800mg). The immediate release
formul
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