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 drug, Spravato, for treating resistant depression as a standalone therapy.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying multiple antidepressants.
Johnson & Johnson noted that nearly 30 percent 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 indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours post-administration and maintained these improvements for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that modify brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most abundant neurotransmitter and facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by approximately 100,000 people across 77 countries, according to Johnson & Johnson.