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AstraZeneca Plc said today that SEROQUEL XR, the
antipsychotic medication that is used to treat schizophrenia, received the Food
and Drug Administration approval.
AstraZeneca, one of the world’s leading pharmaceutical
companies, announced the FDA approved SEROQUEL XR (Quetiapine Fumarate
Extended-Release Tablets) for the acute treatment of bipolar depression and
mania. This is the first FDA-approved drug of this kind.
Bipolar disorder, also known as manic depressive illness, is
a psychiatric diagnosis characterized by extreme mood swings. Unlike normal ups
and downs everyone goes through, the disease involves episodes of abnormally
elevated mood medically referred to as mania or hypomania (literally, below
mania). Bipolar condition affects an individual’s mood, energy and ability to
function. An estimated 8 million adults in the United States are affected by the
disease.
In the long term, people suffering from bipolar disorder “experience
depressive symptoms three times longer than manic symptoms," according to Dr.
Trisha Suppes, Professor of Psychiatry and Behavioral Sciences, Stanford University Medical
Center and VA Palo Alto
Health Care System.
As a result of the approval of the extended-release version
of the bipolar-disorder drug Seroquel, “we have a once-daily treatment that has
been proven to help control the depressive and manic symptoms of bipolar
disorder," Dr. Suppes said.
The FDA approval for the once-daily treatment for bipolar
mania, biopolar depression and mixed biopolar episodes was obtained after the
results of a trial of Seroquel XR, which involved 316 patients with bipolar
mania or mixed episodes with or without psychotic features.
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