Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, to serve as a standalone therapy for treatment-resistant depression.
The FDA originally approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve with two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized in a press release that “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 company’s application is supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours after administration and continued to do so for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily affect neurotransmitters such as serotonin and dopamine, Spravato acts by enhancing glutamate levels in the brain. Glutamate, the most prevalent neurotransmitter, facilitates communication between neurons.
Sales of Spravato surged 60% to $271 million in the quarter ending June 30, compared to the same timeframe in 2023. According to Johnson & Johnson, the drug has already been utilized by 100,000 individuals across 77 countries.