Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used alongside an oral antidepressant for patients whose symptoms did not respond to two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, expressed that many patients dealing with difficult-to-treat depression often endure extended periods trying multiple treatments that fail to alleviate their symptoms, leading to significant emotional and functional burdens for both patients and their families.
The new application is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, began to alleviate patients’ symptoms as soon as 24 hours after administration and continued to be effective 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 affect neurotransmitters like serotonin and dopamine, Spravato primarily enhances glutamate levels in the brain, which is the most abundant neurotransmitter and plays a crucial role in neuronal communication.
In the three months ending June 30, sales of Spravato surged by 60% to $271 million compared to the same period in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.