European Commission approves Spravato nasal spray to treat treatment-resistant major depressive disorder.- Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has approved Spravato (esketamine) nasal spray, in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), for adults living with treatment-resistant major depressive disorder (TRD). According to the approval, 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.

A risk management plan (RMP) will detail the measures to be undertaken to prevent or minimise risks associated with the use of the medicine in patients.