Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) aimed at expanding the approved use of its ketamine-based drug, Spravato, to serve as a standalone treatment for patients with treatment-resistant depression.
Initially approved in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for individuals whose symptoms inadequately responded to two or more other 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 application to the FDA includes data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated symptoms for patients within 24 hours and provided 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 neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to reach $271 million during the quarter ending June 30, compared to the same period in 2022. The drug has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.