Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based drug, Spravato, for use as a standalone treatment for individuals with treatment-resistant depression.
The FDA first granted approval for Spravato in 2019, allowing its use in conjunction with an oral antidepressant for patients who did not respond to two or more traditional antidepressant treatments.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from 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 to the FDA was supported by data from a late-stage clinical trial demonstrating that Spravato, when used alone, alleviated symptoms in patients as quickly as 24 hours post-treatment and sustained improvement for at least four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare professional in a clinical setting. Unlike conventional antidepressants that influence serotonin and dopamine levels, Spravato enhances glutamate function in the brain. Glutamate is the primary neurotransmitter in the brain, facilitating communication between neurons.
In the second quarter of the year, Spravato sales surged 60%, reaching $271 million compared to the same timeframe in 2023. Johnson & Johnson reported that the drug has been utilized by 100,000 patients across 77 countries.