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, as a standalone treatment for patients with treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant for patients who haven’t seen improvement after trying two or more antidepressants.
According to Johnson & Johnson, approximately 30% of the 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
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 application was based on findings from a late-stage clinical trial demonstrating that Spravato, when used alone, began alleviating symptoms as soon as 24 hours after administration and continued to do so for at least four weeks.
Spravato is given as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that modify chemicals like serotonin and dopamine in the brain, Spravato enhances glutamate levels. Glutamate is the brain’s most abundant neurotransmitter and is essential for facilitating communication between neurons.
Sales of Spravato surged 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been utilized by 100,000 individuals across 77 countries.