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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

WILMINGTON, Del., May 8 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of generalized anxiety disorder (GAD), including maintenance of antianxiety effect. It is the first time approval has been sought for an atypical antipsychotic medicine in GAD. The submission is based on a robust clinical development program involving more than three thousand patients. This week, at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, D.C., data from two of the studies (Studies 9 and 12) supporting the submission were presented.

GAD, which affects approximately 6.8 million adults in the U.S., is characterized by persistent anxiety, exaggerated worry and tension. GAD is diagnosed when someone excessively worries about a number of everyday problems for at least 6 months.(1,2) Several classes of drugs have demonstrated efficacy in the treatment of GAD. Treatment typically includes selective- serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs); however, approximately 30 percent of patients do not achieve an adequate response to short-term treatment.(3) Benzodiazepines, commonly prescribed antianxiety medications, may be used for the rapid relief of anxiety symptoms, but long-term use of these agents is not generally recommended.(4)

The GAD submission is based on four Phase III efficacy and safety studies. Three short-term, multicenter, double-blind, randomized, placebo-controlled studies (Studies 9, 10, and 11) compared the safety and efficacy of SEROQUEL XR at doses of 50 mg, 150 mg and 300 mg to placebo for eight weeks in outpatients with GAD. Active controls were also used in Study 10 (escitalopram 10 mg daily) and Study 11 (paroxetine 20 mg daily). These short-
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