Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, to be utilized as a standalone therapy 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 had not improved after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients suffering from hard-to-treat depression endure prolonged periods cycling through various treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA included data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, could relieve patients’ symptoms as soon as 24 hours after administration and for at least four weeks thereafter.
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, which primarily affect serotonin and dopamine levels in the brain, Spravato functions by enhancing glutamate, the brain’s most prevalent neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same timeframe in 2023. According to Johnson & Johnson, the drug has been used by approximately 100,000 individuals across 77 countries.