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 initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms persisted after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide who suffer from 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 as a standalone treatment alleviated symptoms in patients as soon as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that adjust brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and essential for communication between neurons.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that 100,000 individuals in 77 countries have used Spravato.