Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the usage of its ketamine-based medication, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a treatment to be used alongside oral antidepressants for patients who did not see improvement after trying two or more traditional antidepressants.
Approximately 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression, according to the company.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “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 recent application was supported by data from a late-stage clinical trial, which indicated that Spravato, when used alone, could alleviate symptoms in patients as quickly as 24 hours after treatment, with benefits lasting at least four weeks.
Spravato is administered as a nasal spray and requires supervision by a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged by 60% to reach $271 million in the three months ending June 30, compared to the same period in the previous year. Johnson & Johnson reported that the drug has been utilized by 100,000 patients across 77 countries.