-- SEROQUEL is now the first and only single medication approved by the FDA
to treat both depressive and manic episodes associated with bipolar
disorder --
WILMINGTON, Del., Oct. 20 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE:
AZN) today announced that the U.S. Food and Drug Administration (FDA) has
approved SEROQUEL(R) (quetiapine fumarate) for the treatment of patients
with depressive episodes associated with bipolar disorder. SEROQUEL already
is approved for the treatment of acute manic episodes associated with
bipolar I disorder** and for the treatment of schizophrenia. SEROQUEL is
now the first and only single medication approved by the FDA to treat both
depressive and acute manic episodes associated with bipolar disorder.
More than seven million American adults are affected by bipolar
disorder, a serious psychiatric condition also known as manic depressive
illness.(1) Patients with bipolar disorder are symptomatic almost half of
their lives, and approximately two-thirds of that time is spent in the
depressed phase of the illness.(2) For many people with bipolar disorder,
the depressive symptoms are significantly more debilitating than the manic
symptoms associated with the illness.(3)
"The new indication for SEROQUEL provides physicians and their patients
with a single medication to treat both the depressive and manic episodes
associated with bipolar disorder," said John Patterson, Executive Director-
Development, AstraZeneca. "Treating acute bipolar disorder with a single
medication may help patients adhere to their medication regimen."
The FDA approval was based on results from the clinical trial program
known as BOLDER (BipOLar DEpRession), which comprises the BOLDER I and
BOLDER II studies. In these studies, patients taking SEROQUEL showed an
improvement in depressive symptoms* starting at week one compared to those
taking placebo, and this improvement continued throughout the eight-week
study.(4),(5) In addition, patients treated with SEROQUEL showed
significant improvement on other measures of efficacy including overall
quality of life and satisfaction related to functioning.***
Both studies in the BOLDER program were double-blind,
placebo-controlled trials of outpatients (N=1,045) with bipolar I or II
disorder**. Patients were randomized to receive eight weeks of treatment
with fixed doses of SEROQUEL(R) (300 mg or 600 mg) or placebo administered
once-daily. Efficacy in bipolar depression was demonstrated in the studies
at both 300 mg a day and 600 mg a day. No additional benefit was seen in
the 600 mg a day dose groups. Therefore, the recommended dose is 300 mg
once-daily, to be achieved by day four of treatment.
SEROQUEL was generally well tolerated, with adverse event types similar
to those seen in other clinical trials of SEROQUEL in bipolar mania and
schizophrenia.(4),(5) The most frequent adverse events seen in the bipolar
depression trials were dry mouth, sedation, somnolence, dizziness and
constipation.
"Data from the BOLDER clinical trial program demonstrate that SEROQUEL
was safe and effective in treating bipolar depression with significant
decrease in depression scores* as early as week one," said Michael E.
Thase, MD, lead investigator of BOLDER II and Professor of Psychiatry,
University of Pittsburgh School of Medicine. "For many patients with
bipolar disorder, the depressive symptoms are significantly more
debilitating and frequent than the manic symptoms, and having a medication
that effectively treats both acute phases of the illness can be crucial to
the overall treatment process."
Because the depressive symptoms associated with bipolar disorder are
also seen in major depressive disorder, a proper diagnosis can be difficult
to achieve. In fact, studies show that as many as 69% of people with
bipolar disorder were misdiagnosed, with the most frequent misdiagnosis
being major depressive disorder. This misdiagnosis can lead to unfocused
treatment that may exacerbate the disease.(6)
SEROQUEL is the #1 prescribed atypical antipsychotic in the United
States.(7) With a well-established safety and efficacy profile, SEROQUEL
has had more than 19 million patient exposures worldwide since its launch
in 1997. In 2005, global sales for SEROQUEL reached $2.8 billion.
IMPORTANT SAFETY INFORMATION
SEROQUEL is indicated for the treatment of depressive episodes in
bipolar disorder; acute manic episodes in bipolar I disorder, as either
monotherapy or adjunct therapy to lithium or divalproex; and schizophrenia.
Patients should be periodically reassessed to determine the need for
treatment beyond the acute response. SEROQUEL is not approved for the
treatment of major depressive disorder.
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 is not approved
for the treatment of patients with dementia-related psychosis. (see Boxed
Warning)
Suicidality in children and adolescents - antidepressants increased the
risk of suicidal thinking and behavior (4% vs 2% for placebo) in short-term
studies of 9 antidepressant drugs in children and adolescents with major
depressive disorder and other psychiatric disorders. Patients 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(R) is not approved for use in pediatric patients. (see Boxed
Warning)
Prescribing should be consistent with the need to minimize the risk of
tardive dyskinesia. A rare condition referred to as neuroleptic malignant
syndrome has been reported with this class of medications, including
SEROQUEL.
Hyperglycemia, in some cases extreme and associated with ketoacidosis,
hyperosmolar coma or death, has been reported in patients treated with
atypical antipsychotics, including SEROQUEL. 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.
Precautions include the risk of seizures, orthostatic hypotension and
cataract development.
The most commonly observed adverse events associated with the use of
SEROQUEL in clinical trials were dry mouth, somnolence, sedation,
dizziness, asthenia, constipation, abdominal pain, postural hypotension,
pharyngitis, weight gain, SGPT increase, dyspepsia and lethargy.
Please see the full Prescribing Information including Boxed Warnings
for SEROQUEL available at http://www.seroquel.com.
About Bipolar Disorder**
More than seven million American adults are affected by bipolar
disorder, a serious psychiatric condition also known as manic depressive
illness.(1) Bipolar disorder consists of recurring episodes of mania and
depression. Bipolar I disorder is characterized by one or more manic or
mixed episodes, often with episodes of major depression, whereas bipolar II
disorder is distinguished by one or more major depressive episodes
accompanied by at least one hypomanic episode.(8) In the long term,
patients with bipolar I disorder experience depressive symptoms --
including prolonged periods of sadness, loss of energy, persistent
lethargy, and recurring thoughts of death or suicide(9) - three times
longer than manic symptoms.(2) Similarly, patients with bipolar II disorder
spend almost forty times longer in the depressed state than in
hypomania.(10) Bipolar disorder is often misdiagnosed as unipolar
depression. This misdiagnosis can lead to unfocused treatment that may
exacerbate the disease. In fact, many patients face up to ten years without
appropriate treatment before a correct diagnosis is made.(6) Up to 50
percent of patients with bipolar disorder attempt suicide, and
approximately 10 to 15 percent complete suicide.(11)
About AstraZeneca
AstraZeneca is a major international health care 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 $23.95
billion and leading positions in sales of gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infection products. In the United
States, AstraZeneca is a $10.77 billion healthcare business with more than
12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit:
http://www.astrazeneca-us.com
This press release contains forward-looking statements with respect to
AstraZeneca's business. By their nature, forward-looking statements and
forecasts involve risks and uncertainties because they relate to events and
depend on circumstances that will occur in the future. There are a number
of factors that could cause actual results and developments to differ
materially. For a discussion of those risks and uncertainties, please see
the company's Annual Report/Form 20-F for 2005.
References:
1. Hirschfeld RMA, Calabrese JR, Weissman MM, et al. Screening for
Bipolar in the Community. J Clin Psychiatry. 2003; 64:53-59.
2. 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.
3. Calabrese, Hirschfeld 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):1499-504.
4. Calabrese JR, Keck PE, Macfadden W, et al, for the BOLDER Study
Group. A randomized, double-blind, placebo-controlled trial of quetiapine
in the treatment of bipolar I or II depression. Am J Psychiatry. 2005;
162:1351- 1360.
5. Thase ME, Macfadden W, McCoy R, Chang W, Calabrese JR. Confirmation
of the Efficacy of Quetiapine Monotherapy in Bipolar Depression in a Second
Double-Blind, Placebo-Controlled Study: The BOLDER II Study. Presented at
the Annual Meeting of the American Psychiatric Association, 2006, Toronto,
Canada. Poster NR600.
6. 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.
7. All atypical prescriptions: Total prescriptions Jan 06 to August 06.
IMS Health. National Prescription Audit.
8. American Psychiatric Association. Diagnostic and Statistical Manual
of Mental Disorders. Fourth Edition Text Revision. Washington DC: 2000.
9. Introduction to Depression and Bipolar Disorder. Available at:
http://www.dbsalliance.org/PDF/IntroBrochureC2.pdf. Accessed July 28, 2006.
10. 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; 60:26 -269.
11. Oquendo MA, Chaudhury SR, Mann JJ. Pharmacotherapy of Suicidal
Behavior in Bipolar Disorder. Archives of Suicide Research. 2005; 9(3):237-
250.
12. Montgomery-Åsberg Depression Rating Scale (MADRS).
*Depression scores were measured by the Montgomery-Åsberg Depression
Rating Scale (MADRS).(4),(5) The MADRS scale measures the severity of a
number of depressive symptoms including sadness, tension, sleep, appetite,
energy, concentration, and suicidal ideation.(12) The MADRS score decreases
as depressive symptoms improve. In BOLDER I, mean change in MADRS scores
were (-)16.4 for SEROQUEL 300 mg and (-)16.7 for SEROQUEL 600 mg vs.
(-)10.3 for placebo at week eight; (both p's<.001 vs. placebo).4 The
corresponding mean changes in BOLDER II were (-)16.9,(-)16.0, and (-)11.9,
respectively (both p's<.001 vs. placebo). In BOLDER I and II, improvement
in MADRS total score with both doses of SEROQUEL (600 mg/day and 300
mg/day) was significantly greater than placebo at every assessment (p<0.01)
including week one.4
***As measured by Quality of Life Enjoyment and Satisfaction
Questionnaire (QLES-Q).
SOURCE AstraZeneca
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