Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was previously indicated for use alongside an oral antidepressant for patients who did not see improvement 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 prolonged struggles many patients face while trying various treatments that fail to alleviate their symptoms, which can lead to significant emotional and functional challenges for both them and their families.
The application to the FDA includes data from a late-stage clinical trial demonstrating that Spravato, when used alone, can effectively reduce symptoms within 24 hours of treatment and maintain this effect for at least four weeks.
Spravato is administered as a nasal spray and is required to be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily affect neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, facilitating communication between neurons.
Sales figures for Spravato exhibit a substantial increase, rising by 60% to reach $271 million in the quarter ending June 30 compared to the same period in 2023. Johnson & Johnson reports that Spravato has been administered to 100,000 patients across 77 countries.