AstraZeneca today announced that the U.S. Food and Drug Administration(FDA) has approved SEROQUEL® (quetiapine fumarate) for the treatment of patients with depressive episodes associated with bipolar disorder.
SEROQUEL already is approved for the treatment of acute manic episodes associated with bipolar I disorder and for the treatment of
schizophrenia. SEROQUEL is now the first and only single medication
approved by the FDA to treat both depressive and manic episodes
associated with bipolar disorder.
The FDA approval was based primarily on results from the clinical trial programme known as BOLDER (BipOLar DEpRession), which comprises the BOLDER I and BOLDER II studies. In these studies, patients taking SEROQUEL showed an improvement in depressive symptoms starting at week one compared to those taking placebo, and this improvement continued throughout the eight-week study. The recommended dose is 300 mg once-daily, to be achieved by day four of treatment.
More than seven million American adults are affected by bipolar
disorder, a serious psychiatric condition also known as manic depressive illness. Patients with bipolar disorder are symptomatic almost half of their lives, and approximately two-thirds of that time is spent in the depressed phase of the illness. For many people with bipolar disorder, the depressive symptoms are significantly more debilitating than the manic symptoms associated with the illness.
“The new indication for SEROQUEL provides physicians and their patients with a single medication to treat both the depressive and manic episodes associated with bipolar disorder,” said John Patterson, Executive Director Development, AstraZeneca. “Treating acute bipolar disorder with a single medication may help patients adhere to their medication regimen.”
Both studies in the BOLDER programme were double-blind, placebo-controlled trials of outpatients (N=1,045) with bipolar I or II
disorder. Patients were randomized to receive eight weeks of treatment with fixed doses of SEROQUEL® (300 mg or 600 mg) or placebo administered once-daily. Efficacy in bipolar depression was demonstrated in the studies at both 300 mg a day and 600 mg a day. No additional benefit was seen in the 600 mg a day dose groups. Therefore, the recommended dose is 300 mg once-daily, to be achieved by day four of treatment.
SEROQUEL was generally well tolerated, with adverse event types similar to those seen in other clinical trials of SEROQUEL in bipolar mania and schizophrenia. The most frequent adverse events seen in the bipolar depression trials were dry mouth, sedation, somnolence, dizziness and constipation.
Because the depressive symptoms associated with bipolar disorder are
also seen in major depressive disorder, a proper diagnosis can be
difficult to achieve. In fact, studies show that as many as 69 percent of people with bipolar disorder were misdiagnosed, with the most frequent misdiagnosis being major depressive disorder. This misdiagnosis can lead to unfocused treatment that may exacerbate the disease.
Beyond schizophrenia, bipolar mania and bipolar depression, the ongoing clinical development programme includes investigations of the use of SEROQUEL in bipolar maintenance. Regulatory filings for the treatment of schizophrenia with a sustained release formulation of quetiapine fumarate, SEROQUEL SR™, were submitted this year to regulatory authorities in the US, EU and other markets. Ongoing SEROQUEL SR™ clinical studies also cover major depressive disorder and generalized anxiety disorder. SEROQUEL is the number 1 prescribed atypical antipsychotic in the United States. With a well-established safety and efficacy profile, SEROQUEL has had more than 19 million patient exposures worldwide since its launch in 1997. In 2005, global sales for SEROQUEL reached $2.8 billion.