Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 as a supplementary treatment in conjunction with an oral antidepressant for patients who showed no improvement after trying two or more antidepressants. Johnson & Johnson reported that nearly 30 percent of the approximately 280 million individuals worldwide who suffer 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 was supported by data from a late-stage clinical trial demonstrating that Spravato, when administered alone, alleviated patients’ symptoms as quickly as 24 hours post-treatment and sustained relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The medication has been used by over 100,000 individuals across 77 countries, as reported by Johnson & Johnson.