Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) for the expansion of the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a supplementary treatment alongside an oral antidepressant for patients whose symptoms remained unresolved despite trying two or more antidepressants.
According to Johnson & Johnson, approximately 30 percent of the estimated 280 million individuals worldwide who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “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 to the FDA is supported by data from a late-stage clinical trial, indicating that Spravato, as a standalone treatment, demonstrated symptom relief in patients as early as 24 hours after treatment and maintained effectiveness for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that adjust brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and aids in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three-month period ending June 30, compared to the same timeframe in 2022. The drug has been utilized by over 100,000 patients across 77 countries, according to Johnson & Johnson.