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news.AstraZeneca has submitted a supplemental new drug application to the FDA for once-daily Seroquel XR extended-release tablets to seek approval for the treatment of major depressive disorder as monotherapy, adjunct therapy, and maintenance therapy in adult patients.
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The supplemental new drug application (sNDA) is based on seven Phase III, placebo-controlled studies that assessed the efficacy and safety of once-daily treatment with Seroquel XR in patients diagnosed with major depressive disorder (MDD).
Studies one, two, three, and four were acute monotherapy studies involving two, 116 patients; Studies six and seven were acute adjunct therapy studies (with ongoing antidepressant therapy) involving 939 patients who had an inadequate response to an antidepressant therapy; and Study five was a longer-term (up to 78 weeks) monotherapy maintenance study involving 1,854 patients.