Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed for use in combination with an oral antidepressant for patients who have not responded to two or more antidepressants. According to Johnson & Johnson, around 30 percent of the approximately 280 million people globally with major depressive disorder suffer from 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 includes data from a late-stage clinical trial that indicated Spravato, when used alone, can alleviate symptoms within 24 hours and maintain effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that target chemicals like serotonin and dopamine, Spravato targets glutamate, the brain’s most plentiful neurotransmitter, facilitating communication between neurons.
In terms of sales, Spravato saw a significant increase of 60%, reaching $271 million in the quarter ending June 30 compared to the same period in 2023. The medication has been used by 100,000 individuals across 77 countries, according to information from Johnson & Johnson.