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 medication, Spravato, to serve as a standalone therapy for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a treatment option to be used in conjunction with oral antidepressants for patients whose symptoms did not improve after trying two or more traditional antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the 280 million people globally diagnosed with major depressive disorder experience treatment-resistant depression.
“Many patients living with difficult-to-treat depression spend excessive time going through various treatments that fail to alleviate their symptoms, leading to considerable emotional and functional burdens for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application for expanded use includes data from a late-stage clinical trial indicating that Spravato, when used alone, can reduce symptoms of depression within 24 hours and provide relief for at least four weeks.
Spravato is administered as a nasal spray and must be used under the supervision of a healthcare professional in an appropriate healthcare setting. Unlike conventional antidepressants that primarily target chemicals such as serotonin and dopamine, Spravato operates by enhancing the levels of glutamate in the brain. Glutamate is a critical neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, in comparison to the same period in 2023. According to Johnson & Johnson, Spravato has been utilized by 100,000 individuals across 77 countries.