Johnson & Johnson announced on Monday that it has applied to the U.S. Food and Drug Administration (FDA) for approval to use its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was originally approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not see improvement after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the approximately 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 that indicated Spravato, when used as a standalone treatment, alleviated symptoms as quickly as 24 hours after administration, with effects lasting for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances the action of glutamate, the most abundant neurotransmitter in the brain, facilitating neuronal communication.
In terms of sales, Spravato saw a 60% increase, reaching $271 million in the second quarter of the year compared to the same period in 2023. The drug has been used by 100,000 patients across 77 countries, according to Johnson & Johnson.