Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be prescribed as a standalone treatment for patients with treatment-resistant depression.
Spravato received FDA approval in 2019 for use in conjunction with an oral antidepressant for individuals who did not respond to at least two different antidepressants. According to Johnson & Johnson, nearly 30 percent of the 280 million people 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 that demonstrated Spravato’s effectiveness as a standalone treatment, with patients experiencing symptom relief as early as 24 hours after administration and maintaining improvement for at least four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity, which is the most prevalent neurotransmitter in the brain and aids in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30 compared to the same timeframe in 2023. Johnson & Johnson reports that the medication has been utilized by 100,000 patients across 77 countries.