Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug Spravato as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients whose symptoms failed to improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally living with major depressive disorder endure treatment-resistant depression.
“Many patients facing difficult-to-treat depression spend excessive time cycling through various treatments that do not effectively alleviate their symptoms, leading to significant emotional and functional burdens on both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The FDA application includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can begin to alleviate symptoms within 24 hours and continue to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the observation of a healthcare professional in a clinical environment. Unlike typical antidepressants that adjust the levels of chemicals like serotonin and dopamine in the brain, Spravato enhances glutamate activity. Glutamate is the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been utilized by 100,000 individuals across 77 countries.