FDA OKs Esketamine Nasal Spray for Treatment-Resistant Depression – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
Officials with the FDA have approved esketamine CIII nasal spray (Spravato, Janssen Pharmaceutical Companies of Johnson & Johnson) for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). This is the first new mechanism of action in 3 decades to treat major depressive disorder (MDD).1,2
The approval follows a phase 3 clinical trial with more than 1700 adults with TRD. In a short-term study, those who took Spravato and an oral antidepressant experienced superior improvement in depression symptoms at 4 weeks, compared to those who received a placebo and an oral antidepressant. In a long-term study, patients in stable remission taking the medication who continued treatment with the medicine were 51% less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant.