Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
The FDA originally approved Spravato 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 estimated 280 million people globally living with major depressive disorder experience treatment-resistant depression.
“Many patients who struggle with difficult-to-treat depression often endure a prolonged process of trying multiple treatments, which may not effectively alleviate their symptoms, leading to significant emotional and functional challenges for them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, was able to alleviate patients’ symptoms as early as 24 hours after administration and continued to do so for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare professional within a medical setting. Unlike other antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato works by increasing levels of glutamate in the brain, which is the most prevalent neurotransmitter and aids neuronal communication.
Sales of Spravato increased by 60%, reaching $271 million for the three months ending June 30 compared to the same period in 2023. Johnson & Johnson reports that Spravato has been used by 100,000 individuals across 77 countries.