Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, so it can be utilized as a standalone therapy for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant for patients whose symptoms remained unchanged after trying two or more antidepressants.
Johnson & Johnson reported that nearly 30 percent of the approximately 280 million individuals globally with major depressive disorder experience treatment-resistant depression.
Bill Martin, 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 submission for expanded use is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, alleviated symptoms in patients as soon as 24 hours post-treatment and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under the watch of a healthcare professional in a clinical setting. Unlike traditional antidepressants that influence brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels, the most plentiful neurotransmitter in the brain, which facilitates communication between neurons.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.