Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not see improvements with two or more traditional antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients suffering from difficult-to-treat depression often endure long periods while trying various ineffective treatments, which can impose a significant emotional and functional burden on both patients and their families.
The application to the FDA is supported by data from a late-stage clinical trial that demonstrated Spravato, used as a standalone treatment, began to alleviate symptoms as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be consumed under the supervision of a healthcare professional in a medical setting. Unlike other antidepressants that primarily modulate the levels of neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing the activity of glutamate, the brain’s most abundant neurotransmitter, facilitating the communication between neurons.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same period in the previous year. Johnson & Johnson reported that Spravato has been administered to 100,000 individuals across 77 countries.