Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was first approved by the FDA in 2019, but only in conjunction with an oral antidepressant for patients whose conditions did not improve with multiple other antidepressants. According to Johnson & Johnson, nearly 30% of the approximately 280 million people worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application for the expanded indication was supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration and maintained this effect for at least four weeks.
Spravato is delivered as a nasal spray and must be used under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that modify brain chemicals like serotonin and dopamine, Spravato enhances the activity of glutamate in the brain, which is the most abundant neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.