Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, as a standalone therapy for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant, specifically for patients whose symptoms remained unaddressed after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, 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 significant functional and emotional burdens on patients and their loved ones.”
The application is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, showed improvement in patients’ symptoms as quickly as 24 hours after treatment and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider within a medical setting. Unlike traditional antidepressants that influence chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and is crucial for neuronal communication.
Sales for Spravato surged by 60% to $271 million in the second quarter of 2023 compared to the same period last year. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.