Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients who did not find relief from two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 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 to the FDA is supported by data from a late-stage clinical trial that indicated Spravato, when used alone, could alleviate symptoms in patients as quickly as 24 hours after treatment and maintain effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that alter neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the brain’s primary neurotransmitter, facilitating communication between neurons.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30 compared to the same timeframe in 2023, and the medication has been utilized by approximately 100,000 people across 77 countries, as reported by Johnson & Johnson.