Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, to be utilized as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience 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 was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, was able to alleviate patients’ symptoms as quickly as 24 hours post-treatment and continued benefiting them for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily affect chemicals such as serotonin and dopamine, Spravato enhances the levels of glutamate, the brain’s most prevalent neurotransmitter, facilitating neuronal communication.
In financial news, sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 individuals in 77 countries, according to the company.