Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, to allow it to be used as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was indicated for use in conjunction with an oral antidepressant for patients who did not respond to two or more prior 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 is supported by data from a late-stage clinical trial demonstrating that Spravato, when used alone, can alleviate patients’ symptoms as early as 24 hours after treatment and maintains effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30 compared to the same period in 2023. Johnson & Johnson stated that 100,000 individuals in 77 countries have utilized Spravato.