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 drug, Spravato, for use as a standalone treatment for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially indicated for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, noting that many spend extensive periods trying multiple treatments without success, which can create a substantial emotional and functional burden for them and their families.
The submission to the FDA is backed by data from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone therapy, could alleviate symptoms as soon as 24 hours after treatment and maintain efficacy 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 setting. Unlike traditional antidepressants that primarily influence neurotransmitters like serotonin and dopamine, Spravato works by enhancing glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a critical role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023, with the medication having been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.