Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not respond to two or more antidepressants. Johnson & Johnson emphasized that nearly 30 percent of the approximately 280 million individuals worldwide living 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 is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate symptoms within 24 hours and sustain relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under a healthcare provider’s supervision in a clinical setting. Unlike traditional antidepressants that modify serotonin and dopamine levels, Spravato increases glutamate in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
In terms of sales, Spravato experienced a remarkable 60% increase, reaching $271 million in revenue for the three months ending June 30, compared to the same period in 2022. The drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.