FDA News

FDA Approves Astrazeneca's Once-Daily Seroquel XR Extended-Release Tablets for the Treatment of Schizophrenia

(May 17, 2007)-- AstraZeneca announced that the FDA has approved SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients.
The SEROQUEL XR development program was based on the needs of patients and physicians for a wider choice of medicines that offer convenient once-daily dosing. With SEROQUEL XR patients can achieve a dose within the recommended range as early as the second day of treatment.

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 one per cent of the population age 18 and older.

The FDA approval was based on clinical trial data showing effectiveness of SEROQUEL XR at doses of 400, 600, and 800 mg/day. The clinical trial was a placebo-controlled study of inpatients and outpatients
experiencing an acute exacerbation of symptoms of schizophrenia with efficacy assessed using the Positive and Negative Syndrome Scale (PANSS) ratings scale. After six weeks of treatment , patients recorded
a significant improvement in PANSS total scores from baseline for SEROQUEL XR doses of 400, 600, and 800 mg/day, compared with placebo-treated patients.

SEROQUEL XR was generally well-tolerated. The most commonly observed adverse reactions associated with the use of SEROQUEL XR (incidence of 5% or greater) and observed at a rate on SEROQUEL XR at least
twice that of placebo were dry mouth (12%), somnolence (12%), dizziness (10%), and dyspepsia (5%).

"The once-daily dosing of SEROQUEL XR may help patients by providing simpler and more convenient treatment plans, which can be an important component of overall disease management," said Lisa Schoenberg, Vice President, Specialty Care (Neuroscience, Oncology), AstraZeneca.

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