Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for patients with treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with an oral antidepressant for individuals whose conditions have not improved after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression spend too long trying multiple treatments that fail to alleviate their symptoms, which can lead to considerable 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 to the FDA includes data from a late-stage clinical trial that demonstrated Spravato as a standalone treatment can relieve symptoms as quickly as 24 hours after administration and maintain efficacy for at least four weeks.
Spravato is delivered as a nasal spray and needs to be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect chemicals like serotonin and dopamine in the brain, Spravato enhances glutamate levels. Glutamate is the most prevalent neurotransmitter in the brain and facilitates communication between neurons.
In sales news, revenue from Spravato jumped 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been utilized by 100,000 patients across 77 countries.