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 drug, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019, allowing its application in conjunction with an oral antidepressant for patients who did not see improvements after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, commented, “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, as a standalone therapy, alleviated patients’ symptoms as soon as 24 hours after treatment and lasted for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
In terms of financial performance, sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the drug has been utilized by 100,000 individuals across 77 countries.