Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, so that it can be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms had not improved after trying two or more antidepressants. According to Johnson & Johnson, approximately 30% of the estimated 280 million people globally 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 included data from a late-stage clinical trial that indicated Spravato, when used as a standalone treatment, alleviated patients’ symptoms within 24 hours and maintained efficacy 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 other antidepressants that typically target brain chemicals like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same period last year. The medication has been prescribed to over 100,000 patients in 77 countries, according to Johnson & Johnson.