Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, for treatment-resistant depression as a standalone therapy.
Originally approved by the FDA in 2019, Spravato is currently authorized for use in combination with an oral antidepressant for patients whose symptoms do not improve after trying two or more antidepressant medications. Johnson & Johnson highlighted that close to 30% of the approximately 280 million individuals worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, 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 includes data from a late-stage clinical trial demonstrating that Spravato, when administered alone, alleviated patients’ symptoms as quickly as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances the effects of glutamate, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
In recent financial reports, sales of Spravato surged by 60% to reach $271 million in the three months ending June 30, compared to the same quarter last year. Johnson & Johnson noted that Spravato has been utilized by 100,000 individuals across 77 countries.