Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the usage of its ketamine-based drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after two or more antidepressant treatments.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression endure lengthy periods trying various treatments that fail to alleviate their symptoms, which can lead to significant functional and emotional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was supported by data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment alleviated patients’ symptoms as soon as 24 hours after administration and sustained relief 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 medical setting. Unlike traditional antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
In the three-month period ending June 30, sales of Spravato increased by 60% to reach $271 million compared to the same timeframe in 2023. The drug has been utilized by around 100,000 patients across 77 countries, as reported by Johnson & Johnson.