Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, 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 remained unaddressed by two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the around 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 data from a late-stage clinical trial that indicated Spravato, when used as a standalone treatment, provided relief from symptoms as quickly as 24 hours post-treatment and continued to show efficacy for at least four weeks.
Spravato is administered via nasal spray and must be taken under the guidance of a healthcare provider in a medical setting. Unlike traditional antidepressants that primarily target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate, the most prevalent neurotransmitter, is essential for communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same quarter in 2023. To date, Spravato has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.