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 alongside an oral antidepressant, specifically for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, approximately 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression often spend excessive time going through various treatments that fail to alleviate their symptoms, which can impose a significant emotional and functional strain on them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes data from a late-stage clinical trial indicating that Spravato, when used alone, can begin to alleviate symptoms as soon as 24 hours after treatment and sustain this improvement 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 primarily target serotonin and dopamine, Spravato enhances glutamate signaling in the brain. Glutamate, the brain’s most prevalent neurotransmitter, plays a crucial role in facilitating neuronal communication.
Sales of Spravato surged by 60% to $271 million during the three months ending June 30, compared to the same timeframe in 2023. The drug has been used by around 100,000 patients across 77 countries, as reported by Johnson & Johnson.