Johnson & Johnson announced on Monday that it has applied to the U.S. Food and Drug Administration (FDA) for permission to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose conditions did not improve with two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated, “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, which indicated that Spravato, when used alone, could alleviate patients’ symptoms as soon as 24 hours after treatment and maintain effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that target serotonin and dopamine levels in the brain, Spravato enhances glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same time period in 2023. The drug has been utilized by 100,000 individuals in 77 countries, as reported by Johnson & Johnson.