Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based drug, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Spravato originally received FDA approval in 2019, but only for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide affected by major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression endure prolonged periods of trying multiple treatments that fail to alleviate their symptoms, creating significant emotional and functional challenges for both 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 indicating that Spravato, when used as a standalone treatment, can begin to alleviate symptoms as soon as 24 hours after administration and continue to do so for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances levels of glutamate in the brain, a key neurotransmitter that facilitates communication between neurons.
In addition, Spravato’s sales surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been utilized by around 100,000 patients across 77 countries, according to the company.