Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based medication, Spravato, for use as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients whose symptoms were unresponsive to two or more conventional antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “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 significant functional and emotional burdens on patients and their loved ones.”
The application for expanded use was based on data from a late-stage clinical trial indicating that Spravato, when used alone, alleviated patients’ symptoms as early as 24 hours after treatment and continued to provide relief for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that typically target serotonin and dopamine levels in the brain, Spravato operates by enhancing glutamate, the most abundant neurotransmitter in the brain, facilitating communication between neurons.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been used by 100,000 individuals across 77 countries.