Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide who suffer from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression often endure prolonged periods cycling through various treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA was supported by data from a recent late-stage clinical trial, which indicated that Spravato, when used as a standalone therapy, demonstrated the ability to reduce symptoms within as little as 24 hours and sustained 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 focus on regulating neurotransmitters such as serotonin and dopamine, Spravato enhances the activity of glutamate, the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
In the second quarter of the year, sales of Spravato surged 60% to $271 million compared to the same quarter in 2022. Johnson & Johnson reported that Spravato has been prescribed to 100,000 patients across 77 countries.