Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be prescribed as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially authorized Spravato in 2019 as an adjunct to an oral antidepressant for patients whose symptoms failed to improve after trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the 280 million people 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, used as an independent treatment, alleviated patients’ symptoms as soon as 24 hours post-treatment and sustained relief for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under the supervision of a healthcare provider in a clinical environment. Unlike other antidepressants that primarily affect serotonin and dopamine levels, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter in the brain and plays a crucial role in neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.