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, as an independent treatment for those 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 found relief from two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression go through extensive periods trying multiple treatments that do not adequately address their symptoms, which can lead to significant emotional and functional hardships for both the patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The submission to the FDA included findings from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patient symptoms as quickly as 24 hours after administration and persisted for at least four weeks.
Spravato is delivered as a nasal spray and requires administration under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato increases glutamate levels in the brain. Glutamate is the brain’s most prevalent neurotransmitter and plays a crucial role in neuronal communication.
In the three months ending June 30, sales of Spravato surged by 60% to reach $271 million, compared to the same period in 2022. According to Johnson & Johnson, Spravato has been utilized by approximately 100,000 individuals across 77 countries.