Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, to be available as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who had not responded to two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide affected by major depressive disorder experience treatment-resistant depression.
“Many patients with difficult-to-treat depression spend too long trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes data from a late-stage clinical trial demonstrating that Spravato, when used alone, alleviated symptoms in patients as early 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 the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that primarily target neurotransmitters such as serotonin and dopamine, Spravato increases levels of glutamate in the brain, a key neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The drug has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.