THE US Food and Drug Administration (FDA) has approved Spravato esketamine nasal spray monotherapy for the treatment of major depressive disorder in adult patients who have had inadequate response to at least two oral antidepressants.
The approval was based on data from a phase four study that found rapid and superior improvement in depression symptoms, with no new safety concerns reported.
Previously, Spravato had to be taken in conjunction with a newly initiated oral antidepressant, which is the current situation in Australia.
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