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 medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients whose symptoms remained unresolved after trying two or more such medications.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder struggle with 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 create a significant functional and emotional burden on patients and their loved ones.”
The application to the FDA is backed by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate patients’ symptoms as soon as 24 hours post-treatment and maintain effectiveness 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 some other antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances levels of glutamate in the brain, which plays a crucial role in neuronal communication.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has benefited approximately 100,000 people across 77 countries, according to the company.