Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the approved usage of its ketamine-derived medication, Spravato, allowing it to be used as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant specifically for patients whose symptoms did not improve with two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
According to Bill Martin, head of neuroscience at Johnson & Johnson, “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 to the FDA includes findings from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated symptoms in patients as quickly as 24 hours after administration and continued to show effects 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 conventional antidepressants that target chemicals such as serotonin and dopamine, Spravato functions by enhancing levels of glutamate in the brain, which is the most abundant neurotransmitter and is essential for neuron communication.
The sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.