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 utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019, permitting its use in conjunction with an oral antidepressant for patients whose conditions did not improve with two or more traditional antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 is supported by data from a late-stage clinical trial, which indicated that Spravato, used as a standalone treatment, was able to alleviate patients’ symptoms as quickly as 24 hours after administration, maintaining its effectiveness for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a medical facility. Unlike conventional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, the most prevalent neurotransmitter, plays a crucial role in neuronal communication.
In the three months ending June 30, sales of Spravato surged by 60%, reaching $271 million compared to the same timeframe in 2023. So far, the drug has been prescribed to 100,000 individuals across 77 countries, according to Johnson & Johnson.