Drug Topics January 21, 2025
The approval makes Johnson and Johnson’s esketamine nasal spray the first and only monotherapy for the treatment of major depressive disorder in adult patients.
The FDA has approved esketamine (Spravato) for the treatment of major depressive disorder (MDD) in adult patients who have had inadequate response to at least 2 oral antidepressants, Johnson and Johnson announced in a release.1 The decision makes Spravato the first and only monotherapy approved for adults living with the condition.
The approval was based on data from the phase 4 TRD4005 study (NCT04599855), in which the therapy showed a rapid and superior improvement in total score on the Montgomery-Asberg Depression Rating Scale (MADRS). The safety of Spravato as a monotherapy was also found to be...
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