BN003644 03 de janeiro de 2006 11:45 HORALOCAL
Filing Seeks Approval of SEROQUEL as a Monotherapy Treatment for
Bipolar Depression
ALDERLEY PARK, England, Jan. 3 /PRNewswire/ -- AstraZeneca today
announced submission of a supplemental New Drug Application (sNDA) to
the US Food and Drug Administration (FDA) to seek approval for a new
indication for SEROQUEL(R) (quetiapine fumarate) for the treatment of
patients with depressive episodes associated with bipolar disorder.
SEROQUEL is currently approved for the treatment of acute manic
episodes associated with bipolar I disorder and the treatment of
schizophrenia.
"AstraZeneca is dedicated to improving patients' lives and developing
new treatments for mental illness," said Wayne Macfadden, MD, US
Medical Director for SEROQUEL. "This sNDA submission is an important
milestone in the history of SEROQUEL. If SEROQUEL receives approval
from the FDA to treat bipolar depression, it would be the only single
agent indicated to treat both the depressive and manic episodes
associated with bipolar disorder."
The sNDA submission is based on results from the clinical trial
programme known as BOLDER (BipOLar DEpRession), which comprises two
studies: BOLDER I and BOLDER II. Both studies were double-blind,
placebo-controlled trials of outpatients (N=1,045) with bipolar I or
II disorder. Patients were randomised to receive eight weeks'
treatment with fixed doses of SEROQUEL (300 mg or 600 mg) or placebo
administered once daily. In both studies, patients receiving
SEROQUEL, as compared to those receiving placebo, showed a
statistically significant decrease in depression scores at week one,
and scores continued to decrease throughout the eight-week study.
More than half of the SEROQUEL treated patients in each trial met the
criteria for remission.(1)
Additionally, SEROQUEL was shown to have similar safety profiles in
both BOLDER I and II. The most common adverse effects reported in
these trials included dry mouth, sedation, somnolence, dizziness, and
constipation.(1)
Bipolar disorder, which affects more than seven million American
adults(2), consists of recurring episodes of mania and depression.
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.(3) Prolonged periods of sadness,
unexplained loss of energy, persistent lethargy, and recurring
thoughts of death or suicide characterise depressive episodes.(4) Up
to 50 per cent of patients with bipolar depression attempt suicide,
and approximately 10 to 15 per cent commit suicide.(5) Furthermore,
bipolar disorder is often misdiagnosed, and patients may suffer up to
10 years before a correct diagnosis is made.(6)
SEROQUEL(R) (quetiapine fumarate) is the number one prescribed
atypical antipsychotic in the United States(7) and has a
well-established safety and efficacy profile. In 2004, sales for
SEROQUEL reached $2 billion. SEROQUEL has had more than 13 million
patient exposures worldwide since its launch
in 1997.
About Bipolar Disorder
Bipolar I disorder consists of recurring episodes of mania with or
without depression. Bipolar II disorder consists of recurring
episodes of depression and hypomania, a milder form of mania(8). In
the long term, patients with bipolar I disorder spend three times
longer in the depressed state than in mania. Patients with bipolar II
disorder have traditionally been difficult to treat as they spend
almost 40 times longer in the depressed state than in mania.(9)
Without appropriate treatment, patients usually suffer for a lifetime
with periods of wellness and functioning punctuated by severe
episodes of illness. Both men and women are equally at risk for this
illness, which most often emerges in adolescence or young adulthood
and recurs throughout life.(8)
Further Information:
For further information, please go to
http://www.astrazenecapressoffice.com
Notes to Editors:
Depression scores were measured by the Montgomery-Asberg Depression
Rating Scale (MADRS). The MADRS scale measures the severity of a
number of depressive symptoms including mood and sadness, tension,
sleep, appetite, energy, concentration, and suicidal ideation.(10)
The MADRS score decreases as depressive symptoms improve. Remission
was defined as a MADRS score of < / = 12 . In BOLDER I, mean change
in MADRS scores were at week eight from baseline (-)16.7 for SEROQUEL
600 mg and (-)16.4 for SEROQUEL 300 mg vs. (-)10.3 for placebo;
(p<0.001). The corresponding mean changes in BOLDER II were
(-)16.0,(-)16.9, and (-)11.9, respectively (p<0.001).
References
1 Data on file, DA-SER-35
2 Hirschfeld et al. Screening for Bipolar in the Community. J Clin
Psychiatry. 2003;64:53-59.
3 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.
4 Depression and Bipolar Support Alliance (DBSA), 730 N. Franklin
Street, Suite 501, Chicago, Illinois 60610-7224. Introduction to
Depression and Bipolar Disorder. Available at:
http://www.dbsalliance.org/PDF/IntroBrochureC2.pdf . Accessed
December 7, 2005.
5 Hawton, et al. Suicide and Attempted Suicide in Bipolar Disorder:
A Symptomatic Review of Risk Factors. J Clin Psychiatry.
2005;66:693-704.
6 Depression and Bipolar Support Alliance (DBSA). Facts About
Bipolar Disorder. Accessed at
www.dbsalliance.org/media/bipolarfacts.html . Accessed December 7,
2005.
7 All atypical prescriptions: Total prescriptions Jan 05 to Oct 05.
New prescriptions Sept 04 to Oct 05 IMS Health. National
Prescription Audit.
8 Kramlinger K. Mayo Clinic on Depression. Rochester, Minn.: Mayo
Clinic Health Information, 2001.
9 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.
10 Lundbeck Institute. Psychiatric Rating Scales. PDF available at:
http://www.brainexplorer.org/factsheets/Psychiatry%20Rating%20Scales.pdf
. Accessed December 7, 2005.
SOURCE AstraZeneca
01/03/2006
CONTACT: Louise Marland at AstraZeneca, +44-1625-510782, Mobile:
+44-7900-607794, Louise.marland@astrazeneca.com, Maren Koban of Hill
& Knowlton, +44-(0)-20-7973-4497, mkoban@hillandknowlton.com
Web site: http://www.astrazenecapressoffice.com
BNED: NG
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CORAL GABLES - MIAMI-US
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BRASIL-NÉLIA GARCIA
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