Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was permitted for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that approximately 30 percent of the estimated 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 was supported by data from a late-stage clinical trial that demonstrated Spravato could alleviate symptoms as quickly as 24 hours after administration and maintain that 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 environment. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels, the brain’s most prevalent neurotransmitter, facilitating neuron communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period last year. According to Johnson & Johnson, Spravato has been utilized by 100,000 people in 77 countries.