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New Drug Application Submitted for Extended-Release Quetiapine for Generalized Anxiety Disorder

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. 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. 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.

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

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.

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.

Source: AstraZeneca

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