Esketamine is approved in Europe for treating resistant major depressive disorderBMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l7069 (Published 20 December 2019) Cite this as: BMJ 2019;367:l7069
- Elisabeth Mahase
- The BMJ
Esketamine nasal spray—sold under the name Spravato—has been approved by the European Commission (EC) in combination with a selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor, for adults living with treatment resistant major depressive disorder.1
The spray, sold by Janssen (the pharmaceutical branch of Johnson and Johnson), will be made available for patients with the disorder if they have not responded to at least two different treatments with antidepressants.
The approval comes despite criticism over the limited evidence base.
Before the drug can be marketed in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) has to review whether any additional safety requirements need to be implemented. The National Institute for Health and …