Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, to serve as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson has noted that nearly 30 percent of the estimated 280 million people worldwide living with 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 includes data from a late-stage clinical trial indicating that Spravato, used as a standalone treatment, alleviated patients’ symptoms as early as 24 hours post-treatment and maintained 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 typical antidepressants that focus on regulating brain chemicals such as serotonin and dopamine, Spravato operates by increasing the levels of glutamate, the brain’s most abundant neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million during the three months ending June 30, compared to the same quarter in 2023. Moreover, Johnson & Johnson reported that Spravato has been utilized by around 100,000 individuals across 77 countries.