The US Food and Drug Administration (FDA) Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted in favour of Spravato (esketamine) nasal spray CIII for adults living with treatment-resistant depression.
The decision came down to 14 yes votes, two no votes and one abstain, basing their support on the safety and efficacy data from five Phase III studies in patients with treatment-resistant depression: three short-term studies; one maintenance of effect study; and one long-term safety study.
The trial, among others, demonstrated that Spravato nasal spray plus a newly initiated oral antidepressant provided statistically significant, clinically meaningful, rapid, and sustained improvement of depressive symptoms in this difficult-to-treat population.
Janssen, the drug’s manufacturer, announced in September last year that it had submitted a New Drug Application (NDA) to the FDA for the approval of Spravato. If approved, the treatment would provide the first new mechanism of action in 30 years to treat this debilitating mental illness.
While the FDA is not bound by the committee's recommendation, it does take its advice into consideration.
Spravato is a glutamate receptor modulator, thought to help restore synaptic connections in brain cells in people with major depressive disorder. It is believed to have a novel mechanism of action, meaning it is thought to work differently than currently available therapies for major depressive disorder.