Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, so it can serve as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression.
“Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” 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 that indicated Spravato, when used as a standalone treatment, alleviated symptoms for patients as soon as 24 hours post-treatment and for at least four weeks thereafter.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato acts by increasing glutamate levels in the brain. Glutamate is the brain’s most abundant neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.