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. The results from the studies were presented today at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, DC. In February 2008, the company submitted a supplemental new drug application (sNDA) for quetiapine XR for the treatment of MDD as monotherapy, adjunct therapy, and maintenance therapy. AstraZeneca plans to submit an sNDA for quetiapine XR for the treatment of GAD as short-term and maintenance therapy during the second quarter of 2008.
The quetiapine XR clinical development programmes for MDD and GAD included seven Phase III, placebo-controlled studies in MDD as well as four Phase III, placebo-controlled studies in GAD. The three MDD studies presented today investigated once daily quetiapine XR in the treatment of adult patients diagnosed with MDD - as monotherapy in both short-term and maintenance treatment and as short-term adjunct treatment, when compared with placebo.1,2,3 The two GAD studies presented today investigated treatment with quetiapine XR in adult patients diagnosed with GAD - as monotherapy in both short-term and maintenance treatment versus placebo4,5. Across all MDD and GAD studies presented today, efficacy with quetiapine XR was superior to placebo, as assessed by the primary endpoints. In addition, the safety and tolerability of quetiapine XR in these studies were consistent with the known safety profile of quetiapine (further information below).
MDD is the leading cause of disability in the US affecting 15 million American adults and studies have shown that at least one-third of patients with MDD treated with antidepressants fail to achieve a satisfactory response.6,7 GAD affects about 6.8 million adults in the U.S., with women twice as likely to develop it compared to men, and approximately 30% of patients do not achieve an adequate response to acute treatment.8,9,10
AstraZeneca has investigated the use of quetiapine XR, an atypical antipsychotic, in the treatment of MDD as well as GAD, aiming to develop another potential treatment option for patients including those patients who have failed or had an inadequate response to existing 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) and short-term adjunct therapy studies (Studies 6 and 7) used the change in Montgomery-?