SEROQUEL XR is Now Approved to Treat the Depressive, Manic, and
Mixed Episodes of Bipolar Disorder WILMINGTON, Del., Feb. 23
/PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today launched
its once-daily SEROQUEL XR(R) (quetiapine fumarate)
Extended-Release Tablets for the acute treatment of the depressive
episodes associated with bipolar disorder and the manic and mixed
episodes associated with bipolar I disorder, as well as the
maintenance treatment of bipolar I disorder as adjunctive therapy
to lithium or divalproex. SEROQUEL XR is also now available in two
new tablet strengths, 50-mg and 150-mg.(1) Once-daily SEROQUEL XR
is the only medication FDA-approved for the treatment of acute
depressive, manic, and mixed episodes of bipolar disorder.(2)
"Bipolar depression is a serious and debilitating illness with few
approved treatment options," said Dr. Trisha Suppes, Professor of
Psychiatry and Behavioral Sciences, Stanford University Medical
Center and VA Palo Alto Health Care System. "People with bipolar
disorder are known to struggle more frequently with the depressive
rather than the manic symptoms. SEROQUEL XR has been shown to be
effective as a monotherapy in treating bipolar depressive symptoms,
such as sadness, loss of interest, and feelings of worthlessness."
Approximately 8 million American adults may be affected by bipolar
disorder, also known as manic-depressive illness, a serious
psychiatric condition characterized by recurring episodes of
depression and mania.(3,4) For many patients with bipolar disorder,
the depressive symptoms are more disruptive than the manic
symptoms.(5) "When symptomatic, people with bipolar disorder
experience depressive symptoms more than three times longer than
manic symptoms, and this may interfere with daily activities," said
Dr. Arthur Lazarus, Senior Director, Clinical Development for
AstraZeneca. "The approval of SEROQUEL XR for the treatment of
bipolar disorder provides patients with the only medication that
has been proven to treat the acute depressive, manic, and mixed
episodes of bipolar disorder." Today's announcement follows the
October 2008 FDA approval of SEROQUEL XR for these indications in
bipolar disorder. SEROQUEL XR is now available in 50-mg, 150-mg,
200-mg, 300-mg, and 400-mg tablet strengths. SEROQUEL XR is also
approved for the acute and maintenance treatment of
schizophrenia.(1) For the full prescribing information, go to
http://www.seroquelxr.com/. About Bipolar Disorder Approximately 8
million American adults may be affected by bipolar disorder, a
serious psychiatric condition also known as manic depressive
illness.(3,4) Bipolar disorder consists of recurring episodes of
mania and depression.(6) Bipolar I disorder is characterized by one
or more manic or mixed episodes, often with one or more episodes of
major depression, whereas bipolar II disorder is distinguished by
one or more major depressive episodes accompanied by at least one
hypomanic episode.(6) Patients with bipolar I disorder experience
depressive symptoms approximately three times longer than manic
symptoms.(7) Similarly, patients with bipolar II disorder spend
almost forty times longer in the depressed state than in
hypomania.(8) Up to 50 percent of patients with bipolar disorder
attempt suicide, and approximately 15 to 20 percent complete
suicide.(9) Bipolar disorder is often misdiagnosed as major
depressive disorder. This misdiagnosis can lead to unfocused
treatment that may exacerbate the disease. In fact, many patients
face ten years or more before a correct diagnosis is made.(10)
Prior to initiating treatment with an antidepressant, patients with
depressive symptoms should be adequately screened to determine if
they are at risk for bipolar disorder; such screening should
include a detailed psychiatric history, including a family history
of suicide, bipolar disorder, and depression.(1,11) Bipolar
disorder is typically managed through a treatment strategy with
several phases - including acute and maintenance phases. In the
acute phase, the aim is to improve the acute symptoms of the
patient; the maintenance treatment phase aims to reduce the risk of
recurrence of future episodes.(12) Important Safety Information for
SEROQUEL XR SEROQUEL XR is indicated for the treatment of acute
depressive episodes associated with bipolar disorder, acute manic
or mixed episodes associated with bipolar I disorder as monotherapy
and as an adjunct to lithium or divalproex; maintenance treatment
of bipolar I disorder as adjunct therapy to lithium or divalproex,
and acute and maintenance treatment of schizophrenia. Patients
should be periodically reassessed to determine the need for
continued treatment and the appropriate dose. 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.) Antidepressants increased the risk
of suicidal thinking and behavior in children, adolescents, and
young adults in short-term studies of major depressive disorder and
other psychiatric disorders. Patients of all ages started on
therapy should be observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and
caregivers should be advised of the need for close observation and
communication with the prescriber. SEROQUEL XR is not approved for
use in patients under the age of 18 years. (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 reactions 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 periodically during treatment. Patients who
develop symptoms of hyperglycemia should also undergo fasting blood
glucose testing. In long-term clinical trials of quetiapine,
hyperglycemia (fasting glucose greater than or equal to 126 mg/dL)
was observed in 10.7% of patients receiving quetiapine (mean
exposure 213 days) vs. 4.6% in patients receiving placebo (mean
exposure 152 days). Clinically significant increases in cholesterol
(4%-16% for quetiapine vs. 2%-7% for placebo) and triglycerides
(8%-23% for quetiapine vs. 6%-16% for placebo) have been observed
in clinical trials. The proportion of patients in clinical trials
meeting a weight gain criterion of greater than or equal to 7% of
body weight was 5%-23% for quetiapine vs. 0%-7% for placebo. 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. Leukopenia, neutropenia,
and agranulocytosis (including fatal cases), have been reported
temporally related to atypical antipsychotics, including
quetiapine. Patients with a pre-existing low white blood cell (WBC)
count or a history of drug induced leukopenia/neutropenia should
have their complete blood count monitored frequently during the
first few months of therapy. In these patients, SEROQUEL XR should
be discontinued at the first sign of a decline in WBC absent other
causative factors. Patients with neutropenia should be carefully
monitored, and SEROQUEL XR should be discontinued in any patient if
the absolute neutrophil count is < 1000/cubic mm. 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 the 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,
hyperprolactinemia, and possibility of suicide attempts.
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 reported adverse reactions associated
with the use of SEROQUEL XR vs. placebo in clinical trials for
schizophrenia and bipolar disorder were somnolence (25%-52% vs.
10%-13%), dry mouth (12%-37% vs. 1%-7%), constipation (6-10% vs.
3-6%), dyspepsia (5-7% vs. 1-4%), dizziness (10-13% vs. 4-11%),
orthostatic hypotension (7% vs. 5%), weight gain (7% vs. 1%),
increased appetite (12% vs. 6%), fatigue (6-7% vs. 2-4%),
dysarthria (5% vs. 0%), and nasal congestion (5% vs. 1%). Please
see full Prescribing Information, including Boxed Warnings, for
SEROQUEL XR. About AstraZeneca AstraZeneca is engaged in the
research, development, manufacturing and marketing of meaningful
prescription medicines and in the supply of healthcare services.
AstraZeneca is one of the world's leading pharmaceutical companies
with global healthcare sales of $ 31.6 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory,
oncology and infectious disease medicines. In the United States,
AstraZeneca is a $13.5 billion dollar healthcare business. For more
information about AstraZeneca in the US or our AZ&Me(TM)
Prescription Savings programs, please visit:
http://www.astrazeneca-us.com/. The statements contain herein
include forward-looking statements. Although we believe our
expectations are based on reasonable assumptions, any
forward-looking statements, by their very nature, involve risks and
uncertainties and may be influenced by factors that could cause
actual outcomes and results to be materially different from those
predicted. The forward-looking statements reflect knowledge and
information available at the date of the preparation of this press
release and the Company undertakes no obligation to update these
forward-looking statements. Important factors that could cause
actual results to differ materially from those contained in
forward-looking statements, certain of which are beyond our
control, include, among other things, those risk factors identified
in the Company's Annual Report/Form 20-F for 2007. Nothing
contained herein should be construed as a profit forecast.
References 1. SEROQUEL XR(R) (quetiapine fumarate) Extended-Release
Prescribing Information. 2. Data on file, DA-SXR-272661,
AstraZeneca Pharmaceuticals LP. 3. Hirschfeld RMA, Calabrese JR,
Weissman MM, et al. Screening for Bipolar in the Community. J Clin
Psychiatry. 2003; 64:53-59. 4. US Bureau of the Census. Available
at:
http://www.census.gov/popest/national/asrh/NC-EST2005/NC-EST2005-02.xls
. Accessed February 12, 2009. 5. Calabrese JR, Hirschfeld RMA, et
al. Impact of Depressive Symptoms Compared with Manic Symptoms in
Bipolar Disorder: Results of a U.S. Community-Based Sample. J Clin
Psychiatry. 2004;65(11):1499-1504. 6. American Psychiatric
Association (APA). Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition, Text Revision. Washington, DC: APA;
2000; 382-397. 7. Judd LL, Akiskal HS, Schettler PJ, et al. The
Long-term Natural History of the Weekly Symptomatic Status of
Bipolar I Disorder. Arch Gen Psychiatry. 2002; 59:530-537. 8. Judd
LL, Akiskal HS, Schettler PJ, et al. A Prospective Investigation of
the Natural History of the Long-term Weekly Symptomatic Status of
Bipolar II Disorder. Arch Gen Psychiatry. 2003; 60:261 -269. 9.
Oquendo MA, Chaudhury SR, Mann JJ. Pharmacotherapy of Suicidal
Behavior in Bipolar Disorder. Archives of Suicide Research. 2005;
9(3):237-250. 10. Hirschfeld RMA, Lewis L, Vornik LA. Perceptions
and Impact of Bipolar Disorder: How Far Have We Really Come?
Results of the National Depressive and Manic- Depressive
Association 2000 Survey of Individuals With Bipolar Disorder. J
Clin Psychiatry. 2003; 64:161-174. 11. US Food and Drug
Administration. Revisions to Product Labeling.
http://www.fda.gov/cder/drug/antidepressants/antidepressants_label_cha
nge_2007.pdf.Accessed January 27, 2009. 12. American Psychiatric
Association. Practice Guideline for the Treatment of Patients With
Bipolar Disorder, Second Edition. April 2002.
http://www.psychiatryonline.com/pracGuide/loadGuidelinePdf.aspx?file=B
ipolar2ePG_05-15-06. DATASOURCE: AstraZeneca CONTACT: Tracy
Knudsen, +1-302-885-1933, , or Kirsten Evraire, +1-302-885-0435, ,
both of AstraZeneca Web Site: http://www.astrazeneca-us.com/
Copyright