CHMP recommends Spravato nasal spray for adults with treatment-resistant major depressive disorder.- Janssen Cilag

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for 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). 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.

The European marketing authorisation application was primarily based on safety and ef?cacy data from ?ve Phase III studies in patients with TRD: three short-term studies, one randomised withdrawal and maintenance of effect study, and one long-term safety study. Data from these studies, which included more than 1600 esketamine-treated patients, demonstrated that treatment with esketamine nasal spray plus a newly initiated oral antidepressant, compared to a newly initiated antidepressant plus placebo nasal spray as an active standard of care (SOC) comparator, was associated with a reduction in depressive symptoms, as early as day 2.