Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, allowing it to 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 who did not experience improvement with multiple antidepressant treatments. Johnson & Johnson indicated that nearly 30 percent of the estimated 280 million individuals globally diagnosed with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients enduring hard-to-treat depression, stating, “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 to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, used as a standalone therapy, alleviated symptoms in patients within just 24 hours and showed efficacy for at least four weeks of treatment.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider. Unlike traditional antidepressants that target chemicals like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is essential for neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in 2023. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.