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, allowing it to be utilized as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside oral antidepressants in patients who did not see improvement after trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals suffering from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression endure lengthy periods of trying various treatments that fail to alleviate their symptoms, leading to considerable functional and emotional strain on both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application for expanded use was supported by findings from a late-stage clinical trial demonstrating that Spravato, when used alone, showed effectiveness in reducing patients’ symptoms as quickly as 24 hours post-treatment and continued to do so for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a medical environment. Unlike traditional antidepressants that affect brain chemicals such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and essential for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 patients across 77 countries, according to the company.