Johnson & Johnson announced on Monday that it has submitted a petition to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, to function 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 antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the plight of patients dealing with difficult-to-treat depression, stating, “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 is supported by data from a late-stage clinical trial demonstrating 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.
Spravato is delivered through a nasal spray and is required to be administered in a controlled healthcare environment. Unlike traditional antidepressants that typically influence serotonin and dopamine levels in the brain, Spravato enhances glutamate levels, which is the primary neurotransmitter that facilitates communication between neurons.
In recent financial reports, Johnson & Johnson revealed that sales of Spravato surged by 60%, reaching $271 million for the quarter ending on June 30, compared to the same time frame in 2023. The medication has been utilized by 100,000 individuals across 77 countries.