Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be administered as a standalone treatment for patients with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for individuals who did not see improvements after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by patients, stating, “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 for expanded use includes data from a recent late-stage clinical trial, indicating that Spravato, when used alone, can alleviate symptoms as quickly as 24 hours following treatment and maintain its effects 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 medical facility. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato acts by increasing levels of glutamate in the brain, a key neurotransmitter that facilitates communication between neurons.
Sales figures for Spravato indicate a significant increase, with a 60% rise to $271 million in the second quarter, compared to the same period in 2023. Johnson & Johnson reports that approximately 100,000 individuals in 77 countries have utilized Spravato.