Seroquel Evaluation On Improvement In Short And Long-Term Symptoms

Tag : quetiapine fumarate

AstraZeneca (NYSE:AZN) announced new study data on SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets(quetiapine XR) for the treatment of major depressive disorder(MDD) and generalized anxiety disorder (GAD) in adult patients. Theresults from the studies were presented today at the 161st AnnualMeeting of the American Psychiatric Association (APA) inWashington, DC. In February 2008, the company submitted asupplemental new drug application (sNDA) for quetiapine XR for thetreatment of MDD as monotherapy, adjunct therapy, and maintenancetherapy. AstraZeneca plans to submit an sNDA for quetiapine XR forthe treatment of GAD as short-term and maintenance therapy duringthe second quarter of 2008.

The quetiapine XR clinical development programmes for MDD and GADincluded seven Phase III, placebo-controlled studies in MDD as wellas four Phase III, placebo-controlled studies in GAD. The three MDDstudies presented today investigated once daily quetiapine XR inthe treatment of adult patients diagnosed with MDD - as monotherapyin both short-term and maintenance treatment and as short-termadjunct treatment, when compared with placebo.1,2,3 The two GADstudies presented today investigated treatment with quetiapine XRin adult patients diagnosed with GAD - as monotherapy in bothshort-term and maintenance treatment versus placebo4,5. Across allMDD and GAD studies presented today, efficacy with quetiapine XRwas superior to placebo, as assessed by the primary endpoints. Inaddition, the safety and tolerability of quetiapine XR in thesestudies were consistent with the known safety profile of quetiapine(further information below).

MDD is the leading cause of disability in the US affecting 15million American adults and studies have shown that at leastone-third of patients with MDD treated with antidepressants fail toachieve a satisfactory response.6,7 GAD affects about 6.8 millionadults in the U.S., with women twice as likely to develop itcompared to men, and approximately 30% of patients do not achievean adequate response to acute treatment.8,9,10

AstraZeneca has investigated the use of quetiapine XR, an atypicalantipsychotic, in the treatment of MDD as well as GAD, aiming todevelop another potential treatment option for patients includingthose patients who have failed or had an inadequate response toexisting treatments.

Quetiapine XR MDD Clinical Studies

In the quetiapine XR clinical development program in MDD,short-term monotherapy studies (Studies 1, 2, 3, and 4) andshort-term adjunct therapy studies (Studies 6 and 7) used thechange in Montgomery-