Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first authorized by the FDA in 2019 to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more standard antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally 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 lead to a significant functional and emotional burden for patients and their loved ones.”
The application is backed by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone therapy, alleviated patients’ symptoms as soon as 24 hours after administration and sustained improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a qualified healthcare provider in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine levels in the brain, Spravato enhances glutamate activity. Glutamate is the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the medication has been utilized by 100,000 individuals across 77 countries.