Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used in conjunction with an oral antidepressant for patients who did not see improvements after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide living with 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 company’s application is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, alleviated patients’ symptoms within 24 hours of treatment 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 setting. Unlike traditional antidepressants, which typically affect neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is crucial for neuronal communication.
In terms of financial performance, sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reports that Spravato has been utilized by 100,000 patients across 77 countries.