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 treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30% of the approximately 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the struggles faced by patients enduring difficult-to-treat depression, stating, “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 was supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, can alleviate symptoms within 24 hours of administration and maintain those effects for at least four weeks.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider. It functions differently from most antidepressants by enhancing glutamate levels in the brain, rather than regulating serotonin and dopamine, which are commonly targeted by other antidepressants. Glutamate is the most prevalent neurotransmitter in the brain and plays a vital role in neuronal communication.
Sales of Spravato surged by 60% to reach $271 million during the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson reported that the treatment has been utilized by 100,000 patients across 77 countries.