Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, so that it can be utilized as a standalone therapy for treatment-resistant depression.
The FDA originally approved Spravato in 2019, allowing its use in conjunction with an oral antidepressant for patients whose symptoms did not improve after attempting two or more other antidepressants.
According to Johnson & Johnson, roughly 30 percent of the estimated 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 that “many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application to the FDA includes data from a late-stage clinical trial that indicated Spravato, when used as a standalone treatment, could alleviate symptoms in patients within just 24 hours and sustain those effects for a minimum of four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that typically adjust brain chemicals like serotonin and dopamine, Spravato functions by increasing levels of glutamate—the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the medication has been used by 100,000 individuals across 77 countries.