Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, to allow it to be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized 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 experiencing major depressive disorder have treatment-resistant depression.
“Many patients struggling with difficult-to-treat depression often endure long periods cycling through various treatments that fail to adequately address their symptoms, leading to significant emotional and functional challenges for both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales for Spravato surged 60% to $271 million in the quarter ending June 30 compared to the same timeframe in 2023. The drug has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.