Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, to function as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms remained unaddressed despite trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally 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 is supported by data from a late-stage clinical trial, indicating that Spravato, as a standalone treatment, alleviated patients’ symptoms within as little as 24 hours of administration 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 professional in a clinical setting. Unlike many traditional antidepressants that affect neurotransmitters such as serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain. Glutamate is the primary neurotransmitter in the brain, essential for communication between neurons.
Sales for Spravato have significantly increased, rising 60% to $271 million in the three months concluding June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.