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 drug, Spravato, allowing it to be utilized as a standalone treatment for resistant depression.
Initially approved by the FDA in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for patients whose symptoms persist despite attempting two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million global population suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 findings from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated symptoms as early as 24 hours after administration and maintained effectiveness 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 environment. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate, the most prevalent neurotransmitter, plays a crucial role in neuronal communication.
In the three-month period ending June 30, sales of Spravato surged by 60% to $271 million, compared to the same timeframe in 2023. Johnson & Johnson reported that the drug has been used by 100,000 patients across 77 countries.