Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first authorized by the FDA in 2019, but only as an adjunct therapy alongside an oral antidepressant for patients whose symptoms have not improved despite trying two or more other antidepressants. Johnson & Johnson noted that nearly 30 percent of the approximately 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, the 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 submission was backed by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be given under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that typically affect neurotransmitters like serotonin and dopamine, Spravato functions by enhancing levels of glutamate, the brain’s most abundant neurotransmitter, which facilitates 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. Johnson & Johnson reported that the medication has been utilized by 100,000 patients across 77 countries.