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 drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more antidepressants. According to Johnson & Johnson, about 30 percent of the 280 million people worldwide suffering 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 application includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, relieved patients’ symptoms as early as 24 hours after administration and maintained this effect 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 aim to regulate brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, a neurotransmitter essential for neuronal communication.
Sales of Spravato surged by 60 percent to $271 million in the quarter ending June 30, 2023, compared to the same period last year. Johnson & Johnson reported that the drug has been utilized by over 100,000 individuals across 77 countries.