US FDA approves Spravato (esketamine) nasal spray to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behaviour

Approval is based on two phase 3 clinical trials in which esketamine nasal spray, plus comprehensive standard-of-care, demonstrated a significant and rapid reduction of depressive symptoms within 24 hours. Approval is for use in in combination with an oral antidepressant.

SPS commentary:

In the UK, esketamine nasal spray (an NMDA receptor antagonist) is currently only licensed to treat treatment-resistant depressive disorder; potential for a license extension in the UK for this indication is unknown.

PharmaTimes