Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, to function as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for individuals whose depression did not improve after trying two or more traditional antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide living with major depressive disorder suffer from 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 to the FDA was backed by data from a late-stage clinical trial that indicated Spravato, when used alone, could alleviate patients’ symptoms as soon as 24 hours after treatment and maintain improvement for at least four weeks.
Spravato is administered as a nasal spray and requires supervision by a healthcare provider in a clinical setting. In contrast to other antidepressants that primarily affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the most prevalent neurotransmitter and is vital for neuron communication.
Sales of Spravato surged by 60%, reaching $271 million in the second quarter of 2023 compared to the same period in the previous year. The medication has been utilized by 100,000 individuals across 77 countries, according to the company.