Spravato (esketamine) nasal spray approved in Europe for adults with treatment-resistant major depressive disorder

Janssen

19 December 2019 - Esketamine nasal spray offers the first new mechanism of action for an antidepressant in 30 years.

Janssen announced today that the European Commission has approved Spravato (esketamine) nasal spray, in combination with a selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor, 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.

The approval of esketamine is based on data from a clinical trial programme in patients with TRD, including over 1,600 patients treated with esketamine.

Read Janssen press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe