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, to function as a standalone treatment for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially meant to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder suffer from treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression often go through prolonged periods of trialing various treatments that fail to effectively alleviate their symptoms, creating substantial functional and emotional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA includes data from a late-stage clinical trial which indicated that Spravato, when used as a standalone therapy, was able to alleviate patients’ symptoms as early as 24 hours post-treatment and continued to do so for at least four weeks thereafter.
Spravato is administered as a nasal spray and must be taken under the observation of a healthcare provider in a medical setting. Unlike traditional antidepressants that focus on regulating brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter responsible for neuron communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same time frame in 2023. To date, Spravato has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.