Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato is currently indicated for use in conjunction with an oral antidepressant for individuals whose depression does not respond to two or more previous treatments.
The company highlighted that nearly 30 percent of the estimated 280 million individuals globally who suffer 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 cause a significant functional and emotional burden on patients and their loved ones.”
The application to the FDA was supported by results from a late-stage clinical trial, which demonstrated that Spravato, when used alone, alleviated symptoms in patients as soon as 24 hours after administration and sustained improvement for at least four weeks.
Spravato is delivered as a nasal spray and requires administration under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that typically modulate brain chemicals like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter responsible for neuronal communication.
In addition, sales of Spravato surged by 60%, totaling $271 million for the three months ending June 30, compared to the same period in 2023. According to Johnson & Johnson, approximately 100,000 patients in 77 countries have utilized Spravato.