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 used as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in combination with an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder endure treatment-resistant depression.
“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,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours after administration and sustained these benefits 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 focus on regulating neurotransmitters like serotonin and dopamine, Spravato acts by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a critical role in neuronal communication.
Sales of Spravato have surged by 60%, reaching $271 million for the three-month period ending June 30, compared to the same quarter in 2023. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.