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, to serve as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only for use in conjunction with an oral antidepressant for patients whose conditions did not improve with two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide affected by major depressive disorder experience treatment-resistant depression.
“Many patients struggling with difficult-to-treat depression spend excessive time trying various treatments that fail to alleviate their symptoms, leading to substantial emotional and functional distress for both themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application for expanded use was supported by data obtained from a late-stage clinical trial, which demonstrated that Spravato as a standalone treatment significantly alleviated patients’ symptoms as early as 24 hours after administration and sustained improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be used under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a key role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period last year. According to Johnson & Johnson, the medication has been used by 100,000 patients across 77 countries.