AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Major Depressiv...( WILMINGTON Del. Feb. 29 /- AstraZ...)

WILMINGTON, Del., Feb. 29 /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 once- daily SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.

MDD affects 15 million American adults -- between 5 and 8 percent of the population each year -- and today it is often treated with generic or branded antidepressants.(1) Studies have shown that at least one-third of patients with MDD treated with antidepressants fail to achieve a satisfactory response.(2) The American Psychiatric Association Practice Guidelines recommend switching to a medication in another class when two medications from the same class have proven ineffective.(3) AstraZeneca has investigated the use of SEROQUEL XR, an atypical antipsychotic, in the treatment of MDD, aiming to develop another potential treatment option, including treatment for patients who have failed or had an inadequate response to another antidepressant therapy.

The MDD submission is based on seven Phase III, placebo-controlled studies that assessed the efficacy and safety of once-daily treatment with SEROQUEL XR in patients diagnosed with MDD. Studies 1, 2, 3, and 4 were acute monotherapy studies involving 2,116 patients; Studies 6 and 7 were acute adjunct therapy studies (with ongoing antidepressant therapy) involving 939 patients who had an inadequate response to an antidepressant therapy; and Study 5 was a longer-term (up to 78 weeks) monotherapy maintenance study involving 1,854 patients. The acute studies included in this submission used the Montgomery-Asberg Depression Rating Scale (MADRS)* as the primary assessment of depression symptoms. In the longer-term study (Study 5), the primary assessment was time to a depressed event using c
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