Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was permitted for use solely in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 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 to the FDA is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, alleviated patients’ symptoms within 24 hours of treatment and maintained that improvement for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, which is the most abundant neurotransmitter and is crucial for neuron communication.
In addition, Johnson & Johnson reported that sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 individuals across 77 countries.