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, to serve as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve despite trying two or more antidepressants.
According to Johnson & Johnson, approximately 30 percent of the estimated 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, remarked, “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 to the FDA is backed by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone therapy, alleviated patients’ symptoms as quickly as 24 hours after treatment and maintained effectiveness for at least four weeks.
Spravato is administered via a nasal spray and must be taken under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that primarily affect serotonin and dopamine in the brain, Spravato enhances glutamate levels. Glutamate is the most prevalent neurotransmitter in the brain and is essential for neuron communication.
Sales of Spravato surged 60% to $271 million in the second quarter of 2023 compared to the same period in the previous year. Johnson & Johnson reported that Spravato has been utilized by 100,000 individuals across 77 countries.