Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to extend the use of its ketamine-based medication, Spravato, as a standalone treatment for patients suffering from treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with oral antidepressants for individuals whose depression did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million people globally diagnosed with major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression endure prolonged periods of trying various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional strain on both the patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application is supported by data from a late-stage clinical trial indicating that Spravato, when administered alone, can alleviate symptoms as quickly as 24 hours post-treatment and sustain those effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, the most prevalent neurotransmitter in the brain, plays a crucial role in neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been utilized by around 100,000 patients across 77 countries, according to Johnson & Johnson.