ASTRAZENECA'S SEROQUEL APPROVED FOR BIPOLAR DEPRESSIVE EPISODES
The FDA approved AstraZeneca's Seroquel to treat depressive episodes from bipolar disorder, making it the only single medication approved to treat both depressive and manic episodes, the company said. Seroquel is also already approved to treat schizophrenia.
More than 7 million adult Americans have bipolar disorder. When patients are symptomatic, two-thirds of that time is the depressed phase, according to AstraZeneca. The company also said the depressive phases can be much more difficult for patients to endure than the manic phases.
The approval came after studies showed that patients taking Seroquel (quetiapine fumarate) saw improvement in the first week, compared with those who took a placebo. The progress continued throughout the eight-week study. The Seroquel-treated patients also improved in overall quality of life and satisfaction.
AstraZeneca Executive Director of Development John Patterson said having both depressive and manic episodes treated with one pill "may help patients adhere to their medication regime."
Seroquel is the most-prescribed atypical antipsychotic in the U.S., AstraZeneca said. Last year's global sales of the drug reached $2.8 billion.