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AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines
Date:5/8/2008

term studies used the Hamilton Rating Scale for Anxiety (HAM-A)* as the primary assessment of anxiety symptoms.(5-8)

Study 12 was a long-term, multicenter, randomized-withdrawal, parallel- group, placebo-controlled, Phase III study that comprised four phases: an enrollment period of up to 28 days, an open-label run-in treatment period of four to eight weeks, an open-label stabilization treatment period of 12 to 18 weeks, and a randomized-withdrawal treatment period of up to 52 weeks. The SEROQUEL XR dose was flexible: 50 mg, 150 mg, or 300 mg once daily, based on the clinical judgment of the investigator. In this longer-term study, the primary assessment was time from randomization to an anxiety event.(8)

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. SEROQUEL XR is currently not approved for the treatment of bipolar disorder. 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 FOR SEROQUEL XR

SEROQUEL XR is indicated for the acute and maintenance treatment of schizophrenia. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death, compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL XR is not approved for the treatment of patients with dementia-related psycho
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SOURCE AstraZeneca
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