New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annu...(were dry mouth somnolence sedation...),Health

sedation, and constipation. The incidence of serious AEs was <2.5% in

all groups.(4)

-- Study 12 (Poster # NR3-140) -- In a time-to-event, double-blind,

randomized-withdrawal, parallel-group, placebo-controlled study, 433

patients were randomized to SEROQUEL XR or placebo following open-label

stabilization for a minimum of 12 weeks. The SEROQUEL XR dose was

flexible-50 mg, 150 mg, or 300 mg once daily, based on the clinical

judgment of the investigator. The risk of an anxiety event was

significantly reduced for SEROQUEL XR compared with placebo, suggesting

increased time to the event (HR=0.19 [0.12, 0.31]; p<0.001). Twenty-two

(10.2%) SEROQUEL XR-treated patients and 84 (38.9%) placebo-treated

patients experienced an anxiety event. The most common adverse events

(AEs) (greater than or equal to 5% in the SEROQUEL XR group) during the

randomized phase was headache and nasopharyngitis. The incidence of

serious AEs (randomized phase) was <2% in both groups.(5)

About SEROQUEL XR

In 2007, SEROQUEL XR was approved in the U.S. for the treatment of schizophrenia in adult patients and for maintenance treatment of schizophrenia in adult patients. In January 2008, AstraZeneca announced the submission of two separate sNDAs to the FDA for SEROQUEL XR to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder. In February 2008, AstraZeneca filed a sNDA for SEROQUEL XR to seek approval for the treatment of MDD as monotherapy, adjunct therapy, and maintenance therapy. The FDA has not completed its review of these submissions.

IMPORTANT SAFETY INFORMATION SEROQUEL XR

SEROQUEL XR is indicated for the acute and maintenance treatment of schizophrenia. Patients should be periodically reassessed to determ
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