Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-derived medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019, allowing its use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients experiencing difficult-to-treat depression spend far too long cycling through multiple treatments that do not effectively alleviate their symptoms, which can impose a heavy emotional and functional burden on both them and their loved ones.”
The application to the FDA was supported by data from a late-stage clinical trial demonstrating that Spravato, when used alone, could alleviate patients’ symptoms as soon as 24 hours after 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 professional in a clinical environment. Unlike other antidepressant medications that focus on regulating brain chemicals like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter in the brain and is essential for neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been used by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.