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

May 18, 2007, 01:00 ET from AstraZeneca

    WILMINGTON, Del., May 18 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE:  
 AZN) today announced that the U.S. Food and Drug Administration (FDA) has
 approved SEROQUEL XR(TM) (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. (1,5)
     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% 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%). (2)
     "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."
     * Schizophrenic symptomatology is measured on 30-item Positive and
 Negative Syndrome Scale (PANSS) scale. Each symptom was rated on a severity
 scale from 1-7. PANSS positive (7 items), negative (7 items), and general
 psychopathology (16 items) subscale scores were summarized to give the
 PANSS total score. (3)
     SEROQUEL XR is indicated for the treatment of schizophrenia. Patients
 should be periodically reassessed to determine the need for treatment
 beyond the acute response.
     Elderly patients with dementia-related psychosis treated with atypical
 antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death
 compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL XR is not
 approved for the treatment of patients with dementia-related psychosis.
 (See Boxed Warning.)
     Hyperglycemia, in some cases extreme and associated with ketoacidosis,
 hyperosmolar coma, or death, has been reported in patients treated with
 atypical antipsychotics, including quetiapine. The relationship of atypical
 use and glucose abnormalities is complicated by the possibility of
 increased risk of diabetes in the schizophrenic population and the
 increasing incidence of diabetes in the general population. However,
 epidemiological studies suggest an increased risk of treatment-emergent,
 hyperglycemia-related adverse events in patients treated with atypical
 antipsychotics. Patients starting treatment with atypical antipsychotics
 who have or are at risk for diabetes should undergo fasting blood glucose
 testing at the beginning of and during treatment. Patients who develop
 symptoms of hyperglycemia should also undergo fasting blood glucose
     A potentially fatal symptom complex sometimes referred to as
 Neuroleptic Malignant Syndrome (NMS) has been reported in association with
 administration of antipsychotic drugs, including quetiapine. Rare cases of
 NMS have been reported with quetiapine. Clinical manifestations of NMS are
 hyperpyrexia, muscle rigidity, altered mental status, and evidence of
 autonomic instability (irregular pulse or blood pressure, tachycardia,
 diaphoresis, and cardiac dysrhythmia). Additional signs may include
 elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute
 renal failure. The management of NMS should include immediate
 discontinuation of antipsychotic drugs.
     Tardive dyskinesia (TD), a potentially irreversible syndrome of
 involuntary dyskinetic movements, may develop in patients treated with
 antipsychotic drugs. The risk of developing TD and likelihood that it will
 become irreversible are believed to increase as the duration of treatment
 and total cumulative dose of antipsychotic drugs administered to the
 patient increase. TD may remit, partially or completely, if antipsychotic
 treatment is withdrawn. Quetiapine should be prescribed in a manner that is
 most likely to minimize the occurrence of TD.
     Warnings and Precautions also include the risk of orthostatic
 hypotension, cataracts, seizures, hyperlipidemia, and possibility of
 suicide attempt. Examination of the lens by methods adequate to detect
 cataract formation, such as slit lamp exam or other appropriately sensitive
 methods, is recommended at initiation of treatment or shortly thereafter,
 and at 6-month intervals during chronic treatment. The possibility of a
 suicide attempt is inherent in schizophrenia, and close supervision of
 high-risk patients should accompany drug therapy.
     The most commonly observed adverse events associated with the use of
 SEROQUEL XR versus placebo in clinical trials for schizophrenia were dry
 mouth (12% vs 1%), constipation (6% vs 5%), dyspepsia (5% vs 2%), sedation
 (13% vs 7%), somnolence (12% vs 4%), dizziness (10% vs 4%), and orthostatic
 hypotension (7% vs 5%).
     Please see the full Prescribing Information including Boxed Warning for
 SEROQUEL XR available at http://www.astrazeneca-us.com or by calling 1-800-
     About Schizophrenia
     Schizophrenia is a serious brain disorder with symptoms including
 distorted perceptions of reality, hallucinations and delusions, illogical
 thinking, and flat or blunted emotions. (1) Schizophrenia affects men and
 women with equal frequency, but the first signs of schizophrenia typically
 emerge earlier in men (in late teens or early twenties) compared to women
 (in twenties or early thirties). (4) Over 2 million American adults --
 about 1 percent of the population age 18 and older -- suffer from
 schizophrenia. Medications are important in the management of symptoms.
 While there is no cure for schizophrenia, it is a highly treatable and
 manageable illness. Medications are classified into two categories --
 "conventional" and "atypical" antipsychotics. (5)
     About AstraZeneca
     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.
     In the United States, AstraZeneca is a $12.44 billion healthcare
 business with more than 12,000 employees. For nearly three decades,
 AstraZeneca has offered drug assistance programs side by side with its
 medicines, and over the past five years, has provided over $3 billion in
 savings to more than 1 million patients throughout the US and Puerto Rico.
 AstraZeneca has been named one of the "100 Best Companies for Working
 Mothers" by Working Mother magazine and is the only large pharmaceutical
 company named to FORTUNE magazine's 2007 list of "100 Best Companies to
 Work For." In 2006, for the fifth consecutive year, Science magazine named
 AstraZeneca a "Top Employer" on its ranking of the world's most respected
 biopharmaceutical employers.
     For more information about AstraZeneca, please visit:
     The statements herein include forward-looking statements. By their
 nature, forward-looking statements and forecasts involve risk and
 uncertainty. For a discussion of those risks and uncertainties please see
 the company's Annual Report/Form 20-F for 2006.
     (1) American Psychiatric Association. Diagnostic and Statistical Manual
 of Mental Disorders (DSM-IV-TR). Fourth Edition. Arlington, VA, 2000. 299.
     (2) SEROQUEL XR(TM) Prescribing Information.
     (3) Kay et al. Schizophrenia Bulletin. 1987;13:261-276.
     (4) National Institutes of Mental Health. The Numbers Count: Mental
 Disorders in America. NIH Publication No. 06-4584. December 2006.
     (5) National Alliance for the Mentally Ill: About Mental
 Illness/Schizophrenia fact sheet. Reviewed by Kenneth Duckworth, MD:
 February 2007.

SOURCE AstraZeneca