Esketamine for treatment-resistant depression: seven concerns about efficacy and FDA approval

In an editorial published online October 31 in Lancet Psychiatry, Erick H. Turner, MD, who sits on one of the FDA advisory committees that recommended approval of Spravato, said the drug did not meet standard criteria for FDA approval and that there was little evidence to support its safety and efficacy based on data from three short-term, phase 3 trials and one withdrawal trial.