Johnson & Johnson announced on Monday that it has submitted a proposal to the U.S. Food and Drug Administration (FDA) to broaden the usage of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms showed no improvement after trying two or more antidepressants. According to Johnson & Johnson, nearly 30% of the estimated 280 million people 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 recent application includes findings from a late-stage clinical trial indicating that Spravato, when used alone, alleviated patients’ symptoms as quickly as 24 hours after administration and continued to do so for at least four weeks.
Spravato is delivered via nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances glutamate, the most prevalent neurotransmitter in the brain, facilitating better communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same timeframe in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.