Johnson & Johnson announced on Monday that it has filed a request with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-derived medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
The FDA originally authorized Spravato in 2019 as a complementary treatment alongside an oral antidepressant for individuals whose symptoms remained unresolved despite trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide diagnosed with major depressive disorder suffer from treatment-resistant depression.
“Many patients facing challenging-to-treat depression often spend an excessive amount of time trying multiple treatments that fail to effectively alleviate their symptoms, which can place a significant emotional and functional burden on both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was accompanied by data from a recent late-stage clinical trial indicating that Spravato, when used as a standalone treatment, provided symptom relief for patients as soon as 24 hours post-treatment and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under a healthcare provider’s supervision in a clinical setting. Unlike traditional antidepressants that manage chemicals such as serotonin and dopamine in the brain, Spravato enhances glutamate levels. Glutamate is the brain’s most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in the previous year. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.