Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to extend the use of its ketamine-based medication, Spravato, to function as a standalone therapy for treatment-resistant depression.
Spravato, which received initial FDA approval in 2019, was designed to be used 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 approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the struggle faced by patients with hard-to-treat depression. He noted that these patients often face lengthy periods of trying different treatments that offer little relief, leading to significant emotional and functional challenges for themselves and their families.
The application to the FDA is supported by data from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, was able to alleviate patients’ symptoms within 24 hours of administration and sustained its effectiveness for at least four weeks.
Spravato is administered as a nasal spray and requires supervision from a healthcare provider in a medical setting. Unlike traditional antidepressants that typically target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the brain’s most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato increased by 60% to $271 million in the three months ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.