-- Filing Seeks Approval of SEROQUEL as a Monotherapy Treatment for Bipolar
Depression --
WILMINGTON, Del., Dec. 30 /PRNewswire-FirstCall/ -- AstraZeneca
(NYSE: AZN) today announced that it has submitted a supplemental New Drug
Application (sNDA) with 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 program
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 randomized
to receive eight weeks of 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 7 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 characterize depressive
episodes(4). Up to 50 percent of patients with bipolar depression attempt
suicide, and approximately 10 to 15 percent commit suicide(5). Furthermore,
bipolar disorder is often misdiagnosed, and patients may suffer up to ten
years before a correct diagnosis is made(6).
SEROQUEL(R) (quetiapine fumarate) is the #1 prescribed atypical
antipsychotic in the United States(10) 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 forty 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).
IMPORTANT SAFETY INFORMATION
SEROQUEL is indicated for the treatment of acute manic episodes associated
with bipolar I disorder, as either monotherapy or adjunct therapy with lithium
or divalproex, and the treatment of schizophrenia. Patients should be
periodically reassessed to determine the need for continued treatment. It is
recommended that SEROQUEL be taken in divided doses twice daily. SEROQUEL is
not currently approved for the treatment of the depressive phase of bipolar
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.
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(R) (quetiapine fumarate).
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 for schizophrenia and bipolar mania were
somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain,
postural hypotension, pharyngitis, SGPT increase, dyspepsia, and weight gain.
For full Prescribing Information for SEROQUEL, please visit the Web site
http://www.seroquel.com.
ABOUT ASTRAZENECA
AstraZeneca is a major international healthcare 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 over $21.4
billion and leading positions in sales of gastrointestinal, cardiovascular,
respiratory, oncology and neuroscience products. In the United States,
AstraZeneca is a $9.6 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 2004.
References
* Depression scores were measured by the Montgomery-Asberg Depression
Rating Scale (MADRS).1a The MADRS scale measures the severity of a number of
depressive symptoms including mood and sadness, tension, sleep, appetite,
energy, concentration, and suicidal ideation.(7) The MADRS score decreases as
depressive symptoms improve. Remission was defined as a MADRS score of 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 http://www.dbsalliance.org/media/bipolarfacts.html.
Accessed December 7, 2005.
(7) Lundbeck Institute. Psychiatric Rating Scales. PDF available at:
http://www.brainexplorer.org/factsheets/Psychiatry%20Rating%20Scales.pdf.
Accessed December 7, 2005.
(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) All atypical prescriptions: Total prescriptions Jan 05 to Oct 05.
New prescriptions Sept 04 to Oct 05 IMS Health. National Prescription Audit.
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca-us.com
http://www.seroquel.com
Company News On-Call:
http://www.prnewswire.com/comp/985887.html
CONTACT:
Jim Minnick, +1-302-886-5135,
jim.minnick@astrazeneca.com; or Lynn Gionta, +1-302-885-5672,
lynn.gionta@astrazeneca.com, both of AstraZeneca
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