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 used as a standalone treatment for resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not respond to two or more other antidepressant treatments.
According to Johnson & Johnson, nearly 30 percent of the approximate 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the 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 to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, as a standalone treatment, alleviated patients’ symptoms in as little as 24 hours and maintained effectiveness for at least four weeks.
Spravato is administered via a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato enhances the activity of glutamate, the brain’s most plentiful neurotransmitter, crucial for neuronal communication.
Increased sales of Spravato were reported, with a 60% surge to $271 million in the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson revealed that the medication has been utilized by 100,000 individuals across 77 countries.