Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was allowed for use alongside an oral antidepressant for patients who did not achieve relief from their symptoms after attempting two or more different antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the 280 million individuals globally 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 demonstrating that Spravato, when used alone, can alleviate patients’ symptoms as soon as 24 hours after administration and sustain this improvement for at least four weeks.
Spravato is delivered via nasal spray and must be taken under the supervision of a healthcare professional in a controlled medical environment. Unlike traditional antidepressants that influence brain chemicals such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and crucial for neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, approximately 100,000 individuals across 77 countries have utilized Spravato.