18 October 2019 - If approved by the European Commission, esketamine nasal spray will offer the first new mechanism of action in 30 years to treat major depressive disorder.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that theCHMP of the EMA has recommended approval for Spravato (esketamine) nasal spray, in combination with a selective serotonin re-uptake inhibitor or serotonin and norepinephrine re-uptake inhibitor, 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 efficacy data from five 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.

Read Johnson & Johnson press release