Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to extend the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used alongside an oral antidepressant for patients who did not see improvements 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.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “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 was supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as early as 24 hours post-treatment and maintained its effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike conventional antidepressants that target serotonin and dopamine levels in the brain, Spravato enhances glutamate, the most prevalent neurotransmitter, facilitating better communication between neurons.
Sales of Spravato increased by 60%, reaching $271 million in the second quarter compared to the same period in 2023. Johnson & Johnson reported that Spravato has been utilized by 100,000 patients across 77 countries.