Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, to function as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, noting that they often endure lengthy cycles of ineffective treatments that hinder their emotional and functional well-being.
The application to the FDA includes data from a late-stage clinical trial indicating that Spravato can alleviate patients’ symptoms as soon as 24 hours after administration, lasting for at least four weeks. Spravato is given as a nasal spray and must be administered in a healthcare setting under the supervision of a medical professional. Unlike conventional antidepressants that alter serotonin and dopamine levels in the brain, Spravato enhances glutamate levels, the most prevalent neurotransmitter that facilitates communication between neurons.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.