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, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially authorized by the FDA in 2019 for use alongside an oral antidepressant for patients who had not seen improvements from two or more other antidepressant therapies.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide who suffer 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 indicating that Spravato, when used as a standalone therapy, relieved patients’ symptoms as quickly as 24 hours after treatment and sustained its 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 primarily target serotonin and dopamine levels in the brain, Spravato enhances the activity of glutamate, the most prevalent neurotransmitter, facilitating neuronal communication.
Sales for Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reported that the medication has been utilized by over 100,000 individuals across 77 countries.