Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the significant frustration faced by patients dealing with difficult-to-treat depression, stating that many endure lengthy periods cycling through ineffective treatments, leading to considerable emotional and functional strain on both patients and their families.
The application for Spravato’s expanded use included data from a late-stage clinical trial, which demonstrated that the drug could alleviate symptoms as soon as 24 hours after treatment and maintain these effects for at least four weeks.
Spravato is administered via a nasal spray and must be taken in a healthcare setting under the supervision of a healthcare provider. Unlike traditional antidepressants that mainly target neurotransmitters like serotonin and dopamine, Spravato functions by increasing glutamate in the brain, the most prevalent neurotransmitter that facilitates communication between neurons.
Sales for Spravato surged by 60% to $271 million in the quarterly period ending June 30, 2023, compared to the same quarter in the previous year. Johnson & Johnson reported that the drug has been used by 100,000 individuals in 77 countries around the world.