AstraZeneca submits supplemental NDA for Seroquel to treat depressive episodes of bipolar disorder

By E. Janene Geiss

Philadelphia, Dec. 30 - AstraZeneca said Friday that it has submitted a supplemental New Drug Application with the Food and Drug Administration to seek approval for a new indication for Seroquel (quetiapine fumarate) for the treatment of patients with depressive episodes associated with bipolar disorder.

Seroquel currently is approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia, company officials said in a news release.

The sNDA submission is based on results from the clinical trial program known as Bolder (Bipolar Depression), which was comprised of two studies, Bolder I and Bolder II.

Both studies were double-blind, placebo-controlled trials of outpatients 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.

In both studies, patients receiving Seroquel, as compared to those receiving placebo, showed a statistically significant decrease in depression scores at week one and scores continued to decrease throughout the eight-week study, officials said.

More than half of the Seroquel-treated patients in each trial met the criteria for remission, officials said.

Seroquel also was shown to have similar safety profiles in both Bolder I and II. The most common adverse effects reported in these trials included dry mouth, sedation, somnolence, dizziness and constipation.

Bipolar disorder, which affects more than 7 million American adults, consists of recurring episodes of mania and depression.

Seroquel (quetiapine fumarate) is the No. 1 prescribed atypical antipsychotic in the United States and has a well-established safety and efficacy profile, officials said. In 2004, sales for Seroquel reached $2 billion.

AstraZeneca is a London health care business engaged in research, development, manufacture and marketing of prescription pharmaceuticals and the supply of health care services.

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