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 serve as a standalone treatment for individuals with 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 show improvement after trying two or more antidepressant medications.
According to Johnson & Johnson, approximately 30 percent of the 280 million individuals worldwide diagnosed with 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 submission includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours after administration and continued to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that affect chemicals like serotonin and dopamine, Spravato acts by enhancing glutamate levels in the brain. 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, 2023, compared to the same period the previous year. The medication has been utilized by 100,000 individuals across 77 countries, according to the company.