Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was first authorized by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30% of the estimated 280 million individuals worldwide suffering from 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 was supported by data from a late-stage clinical trial demonstrating that Spravato, when used alone, began alleviating patients’ symptoms within 24 hours of treatment and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical environment. Unlike other antidepressants that primarily affect chemicals such as serotonin and dopamine in the brain, Spravato enhances glutamate levels. Glutamate is the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same period in 2022. According to Johnson & Johnson, the drug has been used by 100,000 patients in 77 countries.