Prescribing information for AstraZeneca's quetiapine fumarate (Seroquel) now includes data from a 12-week study that show successful treatment of acute manic episodes associated with bipolar I disorder.
Approximately two-thirds of patients receiving quetiapine achieved remission, according to the results of two identical studies. Both studies were 12 weeks in duration, double-blind, randomized, placebo-controlled trials in 599 patients.
According to AstraZeneca, the new longer treatment period is a benefit to patients, because episodes of mania are unlikely to remit within the first few weeks of treatment. Previously, quetiapine was approved for short-term treatment of acute manic episodes associated with bipolar I disorder. The drug is also approved for treating schizophrenia.