Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, to function as a standalone treatment for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms failed to improve after trying at least two other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 demonstrating that Spravato, when used as a standalone therapy, alleviated patients’ symptoms as early as 24 hours post-treatment and maintained improvement 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 setting. Unlike typical antidepressants that adjust brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels, the most abundant neurotransmitter in the brain that facilitates neuronal communication.
Sales of Spravato surged by 60% to reach $271 million in the three months leading up to June 30, compared to the same period in 2023. According to Johnson & Johnson, Spravato has been utilized by 100,000 individuals across 77 countries.