Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant, specifically for patients who have not found relief after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression often spend excessive time trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for 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 data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, could alleviate patients’ symptoms within 24 hours and maintain improvement for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare professional in an appropriate setting. Unlike traditional antidepressants that affect serotonin and dopamine levels in the brain, Spravato functions by enhancing glutamate activity. Glutamate is the brain’s most prevalent neurotransmitter, essential for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the second quarter of this year, compared to the same period in 2023. Johnson & Johnson reported that the drug has been utilized by 100,000 patients across 77 countries.