New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annu...( - Studies Evaluated Improvement in Sy...),Health

- Studies Evaluated Improvement in Symptoms Both in the Short and Long Term

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WILMINGTON, Del., May 5 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced new study data on SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adult patients. The results from the studies were presented today at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, DC. In February 2008, the company submitted a supplemental new drug application (sNDA) for SEROQUEL XR for the treatment of MDD as monotherapy, adjunct therapy, and maintenance therapy. AstraZeneca plans to submit a sNDA for SEROQUEL XR for the treatment of GAD, including maintenance of antianxiety effect, during the second quarter of 2008.

The SEROQUEL XR clinical development programs for MDD and GAD included seven Phase III, placebo-controlled studies in MDD as well as four Phase III, placebo-controlled studies in GAD. The three MDD studies presented today investigated SEROQUEL XR in the treatment of adult patients diagnosed with MDD-as monotherapy in both short-term and maintenance treatment and as short- term adjunct treatment versus placebo.(1-3) The two GAD studies presented today investigated treatment with SEROQUEL XR in adult patients diagnosed with GAD-as monotherapy in both short-term and maintenance treatment versus placebo.(4,5) Across all MDD and GAD studies presented today, efficacy with SEROQUEL XR was superior to placebo, as assessed by the primary endpoints. In addition, adverse events reported for SEROQUEL XR in these studies were generally similar to those reported in previous clinical trials with quetiapine (See detailed study data below).(1-5)

MDD affects approximately 15 million American adults and studies have shown that at least one-third of patients with MDD treated with antidepressants fa
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