FDA Approves Seroquel XR
FDA Approves Astrazeneca's Once-Daily Seroquel XR Extended-Release Tablets for the Treatment of Schizophrenia
WILMINGTON, Del., May 18, 2007 /PRNewswire-FirstCall/ -- 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 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)
Important Safety Information
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 testing.
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- 236-9933.
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)
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: http://www.astrazeneca-us.com.
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 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. http://www.nimh.nih.gov/publicat/numbers.cfm.
(5) National Alliance for the Mentally Ill: About Mental Illness/Schizophrenia fact sheet. Reviewed by Kenneth Duckworth, MD: February 2007.
Web site: http://www.astrazeneca-us.com/
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Posted: May 2007
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