SEROQUEL XR(R) FDA Approved For Add-On Treatment of Major Depressive Disorder
Posted Dec 04 2009 8:34am
In posting this blog I somewhat seem to notice there’s been a bit of a flurry on antidepressants being approved lately or is it just me, we had Cymbalta approved last week for generalized anxiety treatment.
Seroquel had been approved for the treatment of bi-polar and now it is an add on treatment if you are bipolar and depressed I guess at the same time? If the current antidepressant used is not working well for the patient, MDs can use Seroquel XR as an add on treatment so one more pill can be added on here. Again, perhaps just my observation but there’s certainly a lot of press on treating all types of mental illness these days and I question if we are to look forward to new mental diseases on the horizon to be created? BD
WILMINGTON, Del., Dec. 4 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN - News) today announced that the US Food and Drug Administration (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 (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.(1)(2)
MDD affects approximately 14.2 million American adults in a given year, and today it is often treated with antidepressants(3).( )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(4). Results from a National Institute of Mental Health study, STAR*D, showed that approximately 63% of patients did not achieve remission with the SSRI citalopram when used as a first-line treatment(4). Additionally, this study reported that overall approximately one-third of patients with MDD failed to achieve study defined remission(4). 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.
In addition to the FDA approval for the adjunctive indication in MDD, AstraZeneca has received a Complete Response Letter (CRL) from the FDA asking for additional information for the sNDAs for SEROQUEL XR as acute monotherapy and maintenance monotherapy for the treatment of MDD in adult patients.