Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the usage of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized to be used in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression spend far too long trying multiple treatments that fail to effectively alleviate their symptoms, which can impose significant emotional and functional challenges on both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA included findings from a late-stage clinical study indicating that Spravato, when used alone, may begin to alleviate patients’ symptoms as quickly as 24 hours after treatment and continue to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken under healthcare supervision. Unlike other antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato works by increasing levels of glutamate in the brain, which is the most prevalent neurotransmitter and is crucial for neuron communication.
Sales for Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same quarter in 2023. Johnson & Johnson also reported that the medication has been utilized by 100,000 patients across 77 countries.