Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-derived drug, Spravato, for use as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not respond to two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the 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 impose a significant functional and emotional burden on patients and their loved ones.”
The application includes data from a late-stage clinical trial demonstrating that Spravato as a standalone therapy alleviated patients’ symptoms as quickly as 24 hours after treatment and continued to do so 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 other antidepressants that target chemicals such as serotonin and dopamine in the brain, Spravato functions by increasing the levels of glutamate, the brain’s most abundant neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. The drug has been used by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.