AstraZeneca Submits sNDA for Seroquel XR for the Treatment of Major Depressive Disorder

AstraZeneca 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.