EMA Panel Backs Esketamine Nasal Spray for Resistant Depression Megan Brooks Medscape Medical News, October 18, 2019 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of esketamine nasal spray (Spravato, Janssen-Cilag) in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) for adults with treatment-resistant major depressive disorder (TRD). Patients are considered to have TRD if they have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode. Spravato will be available as a 28 mg nasal spray solution. The safety and [...]
Lire la suite