Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms remained unresponsive after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide with 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 to the FDA includes results from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration and maintained this effect for at least four weeks of treatment.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily affect neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a critical role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.