FDA Approves AstraZeneca's Once-Daily SEROQUEL XR™ Extended-Release Tablets For The Treatment Of Schizophrenia

Main Category: Schizophrenia
Also Included In: Psychology / Psychiatry
Article Date: 20 May 2007 - 9:00 PDT

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AstraZeneca today announced that the U.S. Food and Drug Administration (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 programme 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 two million American adults - about one percent 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 (n=573) 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 (on day 42), 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 percent or greater) and observed at a rate on SEROQUEL XR at least twice that of placebo were dry mouth (12 percent), somnolence (12 percent), dizziness (10 percent), and dyspepsia (5 percent).

"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.

"Clinical trial data demonstrate that SEROQUEL XR is a safe and effective treatment option for schizophrenia," said Dr. Charles Schulz, MD, Professor and Head, Department of Psychiatry, University of Minnesota Medical School. "For many patients with schizophrenia, SEROQUEL XR may offer a viable once daily treatment while decreasing the number of tablets needed to be taken each day."

The US patent for SEROQUEL XR expires in 2017. SEROQUEL XR will be launched in the USA in the second half of 2007. The US is the first country where SEROQUEL XR is licensed - a US press announcement and prescribing information can be found here

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

www.astrazeneca-us.com

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