If approved, Spravato would become the first novel mechanism of action in 30 years to treat major depressive disorder.
Editor's note: The FDA approved esketamine nasal spray on March 5, 2019.
The US Food and Drug Administration (FDA) Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee today voted to recommend Spravato (esketamine) nasal spray CIII for approval. The spray has been developed and tested as a therapy for adults living with treatment-resistant depression.
Between the 2 committees, 14 members voted yes, 2 voted no, and 1 abstained on the matter of the drug's benefits outweighing the risks.
Esketamine, a glutamate receptor modulator, is thought to treat major depressive disorder via a new mechanism of action—helping restore synaptic connections between neurons. If approved, it will be the first novel mechanism of action for treating depression in 30 years.
"We are pleased with the advisory committees' vote and their recommendation to approve Spravato as a potential therapy for adults living with treatment-resistant depression," said Husseini K. Manji, MD, Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. "Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression."
In September 2018, Janssen Pharmaceutical Companies of Johnson & Johnson announced that they had submitted a New Drug Application (NDA) to the FDA for esketamine nasal spray.
The NDA and the Advisory Committees’ decision were supported by data from 5 phase 3 studies of esketamine nasal spray.
Among those were a study that compared 56 or 84 mg esketamine nasal spray plus oral antidepressant versus a placebo-antidepressant regimen dosed over a 16-week period.
Patients in the esketamine group reported significant delayed relapse versus placebo group. Among stable patients in remission, 24 (26.7%) patients given esketamine reported a relapse event during their maintenance phase, versus 39 (45.3%) of patients given placebo (P = .003).
A long-term study conducted over 52 weeks showed no new safety signals compared to the shorter-term phase 3 studies of esketamine nasal spray.
The FDA has granted esketamine nasal spray Breakthrough Therapy Designation for use in treatment-resistant depression as well as for a second indication, major depressive disorder with the imminent risk for suicide.
The FDA’s decision to approve Spravato or not is expected by the Prescription Drug User Fee Act (PDUFA) date, which is set at March 4, 2019.