Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more other antidepressants. Johnson & Johnson noted that 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, highlighted the difficulties faced by patients enduring treatment-resistant 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 includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, successfully alleviated symptoms in patients as quickly as 24 hours after administration and sustained improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider within a clinical setting. Unlike traditional antidepressants that primarily influence serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and is crucial for neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has already been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.