Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients whose symptoms remained unresponsive after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression often spend excessive time cycling through numerous therapies that do not effectively alleviate their symptoms, resulting in significant functional and emotional burdens for both patients and their families,” remarked Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The company submitted its application with data from a late-stage clinical trial that indicated Spravato, when used as a standalone therapy, provided symptom relief for patients as soon as 24 hours post-treatment and maintained that relief for at least four weeks.
Spravato is administered as a nasal spray, requiring supervision from a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato operates by increasing levels of glutamate, the brain’s most abundant neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same time frame in 2023. The medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.