AstraZeneca treatment aims to provide alternative for MDD sufferers
3 March 2008 00:00 in Pharmaceutical Company Product News
A drug developed by AstraZeneca aims to provide sufferers of major depressive disorder (MDD) with an alternative to other generic or branded treatments, the company has explained.
Seroquel XR (quetiapine fumarate) Extended Release Tablets has been submitted for approval as monotherapy, maintenance and adjunct therapy in adult patients.
A total of seven placebo-controlled phase III studies to assess the safety and efficacy of Seroquel XR as a once-daily treatment for MDD sufferers were completed prior to the submission, AstraZeneca said.
Studies one to four were acute monotherapy trials involving 2,116 subjects, while study five was a longer-term monotherapy maintenance study of up to 78 weeks, involving 1,854 patients.
The sixth and seventh were acute adjunct therapy studies and involved 939 subjects, all of which had already experienced an inadequate response to other antidepressant treatment.
AstraZeneca launched the antipsychotic drug in 2007 and it is already approved in 19 countries as a treatment for schizophrenia.
Last week saw the company provide an update on its clinical development programme for Recentin (cederinab, AZD2171).
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