Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for individuals suffering from treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use together with an oral antidepressant, targeting patients whose symptoms did not improve with the use of two or more antidepressant medications. Johnson & Johnson mentioned that nearly 30 percent of the 280 million people globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with tough-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 includes data from a late-stage clinical trial that indicated Spravato can alleviate patients’ symptoms as soon as 24 hours after administration and maintain that improvement for at least four weeks.
Spravato is delivered as a nasal spray and is required to be used under the supervision of a healthcare professional in a clinical setting. Unlike many antidepressants that function by altering levels of serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and aids in neuronal communication.
In terms of sales, Spravato experienced a notable increase of 60%, reaching $271 million in the second quarter of the year compared to the same timeframe in 2023. According to the company, the drug has been utilized by approximately 100,000 individuals across 77 countries.