Johnson & Johnson announced on Monday that it has filed an application with 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 treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, designed to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally afflicted by major depressive disorder experience treatment-resistant depression.
“Patients dealing with tough-to-treat depression often spend excessive time trying various treatments that do not effectively alleviate their symptoms, leading to considerable emotional and functional burdens for them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA included data from a late-stage clinical trial demonstrating that Spravato, when used alone, alleviated symptoms for patients as soon as 24 hours after treatment and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken in the presence of a healthcare provider at a medical facility. Unlike traditional antidepressants that focus on regulating neurotransmitters such as serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales figures for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in 2023. Johnson & Johnson reported that over 100,000 individuals in 77 countries have utilized Spravato.