Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, 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 who did not experience improvement after trying two or more antidepressant medications. According to Johnson & Johnson, approximately 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder have 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, resulting in a significant functional and emotional burden on both patients and their loved ones.”
The application includes data from a late-stage clinical trial which indicated that Spravato, when used as a standalone treatment, alleviated patient symptoms as early as 24 hours after administration and continued to provide relief 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 modify brain chemicals like serotonin and dopamine, Spravato enhances the action of glutamate, the most prevalent neurotransmitter in the brain that facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been utilized by over 100,000 individuals across 77 countries, according to the company.