Alderley Park, England (ots/PRNewswire)
- Filing Seeks Approval of SEROQUEL as a Monotherapy Treatment for
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
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 US$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)
For further information, please go to
Notes to Editors:
Depression scores were measured by the Montgomery-Åsberg
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).
(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:
(5) Hawton, et al. Suicide and Attempted Suicide in Bipolar
Disorder: A Symptomatic Review of Risk Factors. J Clin Psychiatry.
(6) Depression and Bipolar Support Alliance (DBSA). Facts About
Bipolar Disorder. Accessed at
. Accessed December 7,
(7) All atypical prescriptions: Total prescriptions Jan 05 to Oct
05. New prescriptions Sept 04 to Oct 05 IMS Health. National
(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
(10) Lundbeck Institute. Psychiatric Rating Scales. PDF available
les.pdf. Accessed December 7, 2005.
ots Originaltext: AstraZeneca
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