FDA advisors recommend intranasal ketamine in depression

 

Two FDA advisory committees have voted 14-2 in favour of the use of esketamine for treatment-resistant depression (TRD). The advisors found that the intranasal drug is effective in TRD, and that the benefits outweigh the risks. The esketamine program received a Breakthrough Therapy Designation (BTD) in 2013 based on a phase II study of an intravenous formulation in treatment-resistant depression (Singh et al. Biol Psychiatry 2016;80:424-431).

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