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news.Seroquel, which is manufactured by AstraZeneca and already used to treat the manic phases of bipolar disorder, has now been approved in the US for bipolar depression, making it the only drug sanctioned for both indications.
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“Treating acute bipolar disorder with a single medication may help patients adhere to their medication regimen,” said John Patterson, executive director of development at AstraZeneca.
The FDA approval was based on results from studies where patients taking Seroquel showed an improvement in depressive symptoms starting at week one compared to those taking placebo, and this improvement continued throughout the study. In addition, patients treated with Seroquel showed significant improvement on overall quality of life and satisfaction related to functioning.
“For many patients with bipolar disorder, the depressive symptoms are significantly more debilitating and frequent than the manic symptoms, and having a medication that effectively treats both acute phases of the illness can be crucial to the overall treatment process,” said Michael Thase, professor of psychiatry, University of Pittsburgh School of Medicine.
AstraZeneca is currently defending the patent on its Seroquel drug, as Teva Pharmaceuticals is planning to market a generic version of the anti-psychotic drug.
Seroquel is the top prescribed atypical antipsychotic in the US. In 2005, global sales for Seroquel reached $2.8 billion.