Janssen Pharmaceutical has received approval from the US Food and Drug Administration (FDA) for Spravato (esketamine) CIII nasal spray for the treatment of depressive symptoms.
The approval is for use of Spravato spray with an oral antidepressant in adults suffering from major depressive disorder (MDD) with acute suicidal ideation or behaviour.
Spravato is the first approved medicine that could mitigate depressive symptoms within 24 hours, offering an option that provides symptom relief until a long-term treatment plan can take effect.
It acts as a non-selective, non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist.
The effectiveness of the drug in preventing suicide or in decreasing suicidal ideation or behaviour is yet to be demonstrated.
Janssen Research & Development Neuroscience global therapeutic area head Bill Martin said: “People living with major depression need more options to meet their most critical needs, and we’re proud to help redefine how we treat ongoing and acutely worsening depressive symptoms.
“Spravato can now help patients with challenging to treat depression find significant and swift relief from debilitating depressive symptoms, offering those living with this serious mental health condition the possibility of a better future.”
FDA approval is based on two Phase III clinical trials, where Janssen’s drug plus comprehensive standard of care led to a significant, rapid decrease in depressive symptoms within 24 hours.
According to data, some patients started to respond as early as four hours.
In addition, patients in the treatment and placebo groups continued to improve between four hours and 25 days.
Improvement in the severity of suicidality at 24 hours showed no statistically significant on this key secondary endpoint, added Janssen.
The European Commission (EC) approved Spravato nasal spray in December for treatment-resistant major depressive disorder.