Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, 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 who did not see improvement from two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients living with difficult-to-treat depression spend far too long cycling through multiple treatments that fail to effectively alleviate their symptoms, causing significant emotional and functional stress for them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was supported by data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment had begun alleviating symptoms for patients as early as 24 hours post-treatment, maintaining effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike many other antidepressants that affect chemicals such as serotonin and dopamine in the brain, Spravato operates by enhancing glutamate levels. Glutamate is the most prevalent neurotransmitter in the brain, playing a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.