FDA Approves AstraZeneca's SEROQUEL XR(R) for the Treatment of Bipolar Depression and Bip...(supplemental new drug applications(sNDAs...)

Date:10/10/2008

supplemental new drug applications (sNDAs) to the FDA to seek approval for these indications. The bipolar depression submission was supported by a clinical study of treatment with SEROQUEL XR compared with placebo in 280 patients diagnosed with bipolar depression.(5,6) The primary endpoint was change from baseline in MADRS(*) (Montgomery-Asberg Depression Rating Scale) total score compared to placebo at week 8. In the study, SEROQUEL XR at 300 mg once-daily was significantly more effective than placebo. The mean change in MADRS total score from baseline to Week 8 was -17.4 for SEROQUEL XR compared with -11.9 for placebo (p<0.001). In the bipolar depression trial, the most common adverse events (AEs) (greater than or equal to 5% and at least twice placebo) associated with SEROQUEL XR compared with placebo were somnolence (combined adverse events terms somnolence and sedation) (52% vs. 13%), dry mouth (37% vs. 7%), increased appetite (12% vs. 6%), weight gain (7% vs. 1%), dyspepsia (7% vs. 1%), and fatigue (6% vs. 2%).(5)

The bipolar mania submission was based on a clinical study of treatment with SEROQUEL XR compared with placebo in 316 patients with bipolar mania or mixed episodes with or without psychotic features.(5,8) The primary endpoint was change from baseline in YMRS(**) (Young Mania Rating Scale) total score compared to placebo at week 3. The study showed that SEROQUEL XR at 400 mg to 800 mg (mean dose 604 mg) once-daily produced a significantly greater improvement in YMRS scores from baseline to endpoint compared with placebo (- 14.34 vs. -10.52; p<0.001). In the bipolar mania trial, the most common adverse events (AEs) (greater than or equal to 5% and at least twice placebo) associated with SEROQUEL XR compared with placebo were somnolence (combined adverse events terms somnolence and sedation) (50% vs. 12%), dry mouth (34% vs. 7%), dizziness (10% vs. 4%), constipation (10% vs. 3%), weight gain (7% vs. 1%), dysarthria (5% vs. 0%), and nasal congesti
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