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, for treatment-resistant depression as a standalone therapy.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who have not seen improvement after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the difficulties faced by patients who struggle with hard-to-treat depression, stating that many endure prolonged cycles of ineffective treatments, resulting in considerable emotional and functional burdens on both the patients and their families.
The new application is supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can alleviate symptoms within 24 hours and provide relief for at least four weeks.
Spravato is administered through a nasal spray method and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that alter brain chemicals such as serotonin and dopamine, Spravato functions by increasing levels of glutamate, the brain’s most abundant neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same period last year. Johnson & Johnson reports that the drug has been utilized by 100,000 individuals across 77 countries.