Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, to allow it to be utilized as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients who did not see improvement after trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals globally diagnosed with major depressive disorder suffer from 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 significant functional and emotional burdens on patients and their families.”
The application for expanded use was supported by data from a late-stage clinical trial, which demonstrated that Spravato as a standalone treatment could alleviate patients’ symptoms as quickly as 24 hours after administration and sustained relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target the regulation of neurotransmitters like serotonin and dopamine, Spravato operates by increasing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato experienced a significant surge, rising 60% to $271 million for the quarter ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reported that Spravato has been utilized by approximately 100,000 patients across 77 countries.