Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved application of its ketamine-based medication, Spravato, for use as a standalone therapy in treating resistant depression.
Spravato was initially approved by the FDA in 2019 as a treatment in combination with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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 includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, was effective in alleviating symptoms as early as 24 hours after administration and continued to provide relief for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a key role in neuron communication.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the drug has been utilized by 100,000 patients across 77 countries.