Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially intended to be used in conjunction with an oral antidepressant for patients whose depressive symptoms did not improve despite trying two or more antidepressants.
According to Johnson & Johnson, approximately 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 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 create a significant functional and emotional burden on patients and their loved ones.”
The application to the FDA is supported by data from a late-stage clinical trial that indicated Spravato, when used alone, alleviated patients’ symptoms as quickly as 24 hours after the treatment and maintained that improvement for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare professional in a designated healthcare setting. Unlike traditional antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, the most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato increased by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.