Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved application of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with 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 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated in a press release, “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.”
The application includes results from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, alleviating patients’ symptoms as quickly as 24 hours after administration and lasting for at least four weeks.
Spravato is administered as a nasal spray and requires supervision from a healthcare provider in a medical setting. Unlike other antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most abundant neurotransmitter and facilitates communication between neurons.
In the three months ending June 30, sales of Spravato surged by 60%, reaching $271 million compared to the same period in 2023. The drug has been used by over 100,000 individuals in 77 countries, as reported by Johnson & Johnson.