Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to enhance the approved use of its ketamine-derived medication, Spravato, allowing it to be utilized as a standalone therapy for patients with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
Approximately 30 percent of the 280 million people globally suffering from major depressive disorder experience treatment-resistant depression, according to Johnson & Johnson.
“Many patients facing difficult-to-treat depression spend an excessive amount of time going through various treatments that fail to alleviate 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 includes data from a late-stage clinical trial that indicated Spravato, when used alone, could alleviate symptoms as quickly as 24 hours after administration, continuing for at least four weeks of treatment.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and is crucial for neuronal communication.
Sales of Spravato surged by 60% to $271 million during the second quarter ending June 30, compared to the same period in the previous year. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.