Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be employed 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 after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from 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 a significant functional and emotional burden on patients and their loved ones.”
The application is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, can alleviate patients’ symptoms as quickly as 24 hours post-treatment and maintain that improvement for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that adjust brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the brain’s most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato experienced a 60% increase, reaching $271 million in the three months ending June 30 compared to the same period in 2023. The drug has been prescribed to 100,000 individuals across 77 countries, according to Johnson & Johnson.