Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to allow its ketamine-derived medication, Spravato, to be used as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was indicated to be used in combination with an oral antidepressant for patients whose symptoms remained unresolved despite trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that “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 submission to the FDA is supported by data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, showing improvements in patients’ symptoms as quickly as 24 hours after administration and sustaining relief for at least four weeks.
Spravato is delivered via a nasal spray and requires administration under the supervision of a healthcare professional in a clinical setting. Unlike conventional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates neuron communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. As reported by Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.