Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking approval to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose condition did not improve with at least two other antidepressants. According to Johnson & Johnson, approximately 30 percent of the 280 million people 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 cause a significant functional and emotional burden on patients and their loved ones.”
The application was submitted along with data from a late-stage clinical trial demonstrating that Spravato, when used alone, provided relief from symptoms as quickly as 24 hours after administration and maintained this effect 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 serotonin and dopamine levels in the brain, Spravato increases glutamate activity. Glutamate is the brain’s most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato have surged by 60%, reaching $271 million during the three months ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to the company.