Johnson & Johnson announced on Monday that it has filed an application with 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 treatment-resistant depression.
Spravato received its initial FDA approval in 2019, but only for use in conjunction with an oral antidepressant, aimed at patients whose symptoms did not improve despite trying two or more antidepressants.
The company indicated that nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients struggling with difficult-to-treat depression spend a lengthy period navigating through various treatments that fail to alleviate their symptoms, causing significant emotional and functional challenges for both themselves 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 that indicated Spravato, when used alone, reduced patients’ symptoms as quickly as 24 hours post-treatment and maintained that improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare setting under professional supervision. Unlike other antidepressants that affect brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most common neurotransmitter and facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.