AstraZeneca Submits Seroquel sNDA

AstraZeneca has submitted an sNDA to the FDA for a new indication for Seroquel for the treatment of patients with depressive episodes associated with bipolar disorder. Seroquel is currently approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia.

The sNDA submission is based on results from the BOLDER I and BOLDER II (BipOLar DEpRession) trial programs. 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 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. More than half of the Seroquel treated patients in each trial met the criteria for remission. Seroquel 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.