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.
The FDA originally approved Spravato in 2019 as a combination treatment alongside an oral antidepressant for patients who did not respond to two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients living with challenging-to-treat depression spend too long cycling through multiple treatments that do not effectively alleviate their symptoms, imposing a significant emotional and functional burden on them and their families,” said Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application is supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can relieve symptoms within 24 hours and maintain effectiveness for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider in a medical facility. Unlike traditional antidepressants that focus on altering brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and aids in neuronal communication.
Sales of Spravato increased by 60%, reaching $271 million for the quarter ending June 30, compared to the same timeframe in 2023. The drug has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.