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AstraZeneca Submits sNDA For Seroquel(R) For
Bipolar Depression Treatment
03 de janeiro de 2006 11:45 HORALOCAL
AstraZeneca Submits sNDA For Seroquel(R) For
Bipolar Depression Treatment
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
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