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Quetiapine (pronounced /kwəˈtɑɪəpiːn/, kwe-TYE-a-peen), marketed by AstraZeneca as Seroquel and by Orion Pharma as Ketipinor, is an atypical antipsychotic used
in the management of schizophrenia and bipolar I disorder, and used off-label for a variety of other purposes, including insomnia and anxiety disorders.
Annual sales are approx. $4.7bn. The patent expires in 2011, however in Canada it has already expired. Several pharmaceuticals companies are now making generic
versions of Quetiapine.
Quetiapine is indicated for the treatment of schizophrenia, depressive episodes associated with bipolar disorder, acute manic episodes associated with bipolar I disorder
(as either monotherapy or adjunct therapy to lithium or divalproex), and maintenance treatment of bipolar I disorder (as adjunct therapy to lithium or divalproex). Quetiapine
received its initial indication from the U.S. Food and Drug Administration for treatment of schizophrenia in 1997. In 2004, it received its second indication for the treatment
of mania-associated bipolar disorder. It is sometimes used off-label, often as an augmentation agent, to treat such conditions as obsessive-compulsive disorder,
post-traumatic stress disorder, restless legs syndrome, autism, alcoholism, Tourette syndrome, and has been used by physicians as a sedative for those with sleep
disorders or anxiety disorders.
In 2005, Quetiapine and other antipsychotics were shown by the New England Journal of Medicine to be no more effective than perphenazine (Trilafon), a typical
antipsychotic, for the treatment of schizophrenia. However, the subsequent CATIE trial, funded by AstraZeneca and other major pharmaceutical
manufacturers,contradicted the 2005 study in certain instances.
A 2005 British Medical Journal report showed that Quetiapine was ineffective in reducing agitation among Alzheimer's patients, whose consumption of the drug then
constituted 29% of sales; in fact, Quetiapine was found to make cognitive functioning worse in elderly patients with dementia.
Use of Quetiapine to minimize the symptoms of opioid withdrawal has been studied.
Phase III trials are being conducted to prove Quetiapine's efficacy in treating generalized anxiety disorder and major depressive disorder as of January 2007. The company
expects to file a New Drug Application for treating generalized anxiety disorder in the second half of 2007 and for major depressive disorder in 2008.
AstraZeneca's patent for Seroquel expires in September 2011, which will allow other companies to manufacture and market quetiapine.
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