Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to extend the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who did not respond to two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “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 for standalone use was supported by data from a late-stage clinical trial indicating that Spravato could relieve patients’ symptoms as early as 24 hours after treatment, with effects lasting 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 alter levels of neurotransmitters such as serotonin and dopamine, Spravato works by increasing glutamate levels in the brain, which is the most prevalent neurotransmitter and is crucial for neuron communication.
Sales of Spravato experienced a significant increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been used by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.