Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, 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 whose symptoms failed to improve after two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the struggles faced by patients with hard-to-treat depression, noting the emotional and functional burdens they endure while trying various ineffective treatments.
The application to the FDA is supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can alleviate symptoms in patients as soon as 24 hours after administration and maintain efficacy for at least four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances the action of glutamate, the most abundant neurotransmitter in the brain, facilitating communication between neurons.
In the second quarter of this year, sales of Spravato surged by 60%, reaching $271 million, compared to the same period in 2023. Johnson & Johnson reports that Spravato has been utilized by approximately 100,000 patients across 77 countries.