Johnson & Johnson announced on Monday that it has filed a request with the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, allowing it to be considered as a standalone therapy for patients suffering from treatment-resistant depression.
The FDA initially approved Spravato in 2019, permitting its use in conjunction with an oral antidepressant for individuals whose symptoms failed to improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the roughly 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, highlighted the struggles faced by patients dealing with difficult-to-treat depression, stating that many endure prolonged periods of trialing various treatments that do not effectively alleviate their symptoms, which can impose a significant emotional and functional burden on both patients and their families.
The company’s application to the FDA is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, began to alleviate symptoms within 24 hours and continued to do so for at least four weeks.
Spravato is administered as a nasal spray and requires supervision by a healthcare provider in a healthcare environment. Unlike traditional antidepressants that primarily influence neurotransmitters such as serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, which is the most prevalent neurotransmitter and is vital for neuronal communication.
In terms of market performance, Spravato’s sales surged by 60%, reaching $271 million in the quarter ending June 30 compared to the same timeframe in 2023. Johnson & Johnson reports that approximately 100,000 individuals in 77 countries have utilized Spravato.