Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, to be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019, permitting its use alongside an oral antidepressant for patients whose symptoms failed to improve despite taking two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals globally affected by major depressive disorder suffer from treatment-resistant depression.
“Many patients facing difficult-to-treat depression spend far too long cycling through various treatments that do not effectively alleviate their symptoms, resulting in significant functional and emotional strain on both patients 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 demonstrating that Spravato, when used as a standalone therapy, could relieve patients’ symptoms as quickly as 24 hours post-treatment and maintain efficacy for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants, which typically affect serotonin and dopamine levels in the brain, Spravato enhances glutamate activity. Glutamate, the most prevalent neurotransmitter in the brain, is essential for neuronal communication.
Sales of Spravato increased by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been utilized by 100,000 individuals across 77 countries.