Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.AstraZeneca has submitted applications in the EU for once-daily Seroquel XR Extended-Release Tablets, seeking approval for the treatment of major depressive disorder including maintenance therapy in adult patients using the mutual recognition procedure.
Subscribe to our email newsletter
Seroquel XR is said to be the first atypical antipsychotic medicine to be submitted in Europe for approval for the treatment of major depressive disorder (MDD). AstraZeneca has investigated its use in MDD as a potential new treatment option for patients who do not respond adequately to current treatments.
Data from eight randomized placebo-controlled studies of quetiapine XR at once-daily doses of 50, 150 and 300 mg in patients diagnosed with MDD support the submission announced today. These include four short-term monotherapy studies involving 2116 patients; two short-term adjunct therapy studies (with ongoing antidepressant therapy) involving 939 patients who had an inadequate response to prior antidepressant therapy; a longer-term monotherapy maintenance study involving 1,854 patients and up to 78 weeks of treatment; and a further short-term study involving 338 elderly patients.
The short-term studies demonstrated that quetiapine XR reduced depressive symptoms by week one whilst the long-term study demonstrated that efficacy was maintained. The safety and tolerability of quetiapine XR was consistent with the known safety profile of quetiapine.
AstraZeneca’s clinical development program for quetiapine XR includes studies in generalized anxiety disorder and a European submission for that indication is planned for the second half of 2008.