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, as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying 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, 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 includes data from a late-stage clinical trial indicating that Spravato, used as a standalone treatment, alleviated symptoms in patients as quickly as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three months leading up to June 30, compared to the same period in 2023. The drug has now been utilized by 100,000 individuals across 77 countries, according to the company.