Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was first approved by the FDA in 2019, but only for use alongside an oral antidepressant for patients whose symptoms did not improve with two or more traditional antidepressants. According to Johnson & Johnson, nearly 30 percent of the 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression.
“Many patients living with difficult-to-treat depression spend far too long cycling through multiple treatments that fail to resolve their symptoms, resulting in significant functional and emotional burdens on both patients and their loved ones,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application includes data from a late-stage clinical trial indicating that Spravato, when administered as a standalone treatment, can alleviate symptoms as soon as 24 hours after use and continues to be effective for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under a healthcare provider’s supervision in a clinical setting. Unlike traditional antidepressants that modify chemicals like serotonin and dopamine in the brain, Spravato enhances glutamate levels, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales of Spravato increased by 60 percent, reaching $271 million in the three months ending June 30 compared to the same period in the previous year. According to Johnson & Johnson, the drug has been utilized by 100,000 individuals across 77 countries.