Friday, AstraZeneca Plc (AZN, AZN.L) announced that the US Food and Drug Administration or FDA has approved once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder or MDD. SEROQUEL XR is the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy, the company said.
MDD affects around 14.2 million American adults in a given year, and today it is often treated with antidepressants. Selective serotonin reuptake inhibitors, or SSRIs, are among the most commonly prescribed class of antidepressant medications for depression; however, in many cases patients fail to respond adequately to treatment.
Results from a National Institute of Mental Health study, STAR*D, showed that about 63% of patients did not achieve remission with the SSRI citalopram when used as a first-line treatment. Additionally, this study reported that overall approximately one-third of patients with MDD failed to achieve study defined remission. This approval for SEROQUEL XR provides physicians with a new adjunctive treatment option for patients with MDD who have an inadequate response to their current antidepressant, AstraZeneca said.
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