Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the usage of its ketamine-based drug, Spravato, to be used as an independent treatment for individuals suffering from treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed for use in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants. The company highlighted that nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the 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 was supported by data from a late-stage clinical trial, which indicated that Spravato, when used alone, was effective in alleviating patients’ symptoms within 24 hours of administration and continued to do so for at least four weeks.
Spravato is administered via nasal spray and must be given under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that target brain chemicals such as serotonin and dopamine, Spravato operates by enhancing glutamate levels, the brain’s most abundant neurotransmitter, which facilitates communication among neurons.
Sales figures for Spravato demonstrated a 60% surge, reaching $271 million in the quarter ending June 30, compared to the same quarter last year. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.