Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) for the approval of its ketamine-based medication, Spravato, to be used as a standalone treatment for those suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in combination with an oral antidepressant for patients who did not see improvements after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally diagnosed with major depressive disorder experience treatment-resistant depression.
“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,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The submission was backed by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, showed improvement in patients’ symptoms as early as 24 hours after administration and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants, which typically target chemicals like serotonin and dopamine, Spravato increases glutamate levels in the brain. Glutamate is the most plentiful neurotransmitter, essential for neuronal communication.
In terms of financial performance, Sales of Spravato increased by 60% to $271 million for the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by roughly 100,000 individuals across 77 countries, as noted by Johnson & Johnson.