Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
The FDA originally approved Spravato in 2019, but only in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated, “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 was supported by data from a late-stage clinical trial indicating that Spravato, when used alone, was able to alleviate patients’ symptoms within 24 hours and maintain those improvements 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 focus on regulating chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and is essential for neuron communication.
Sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the drug has been utilized by 100,000 individuals across 77 countries.