Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, to allow for its use as a standalone therapy for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 to be used in conjunction with an oral antidepressant for patients whose symptoms persist despite trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder have 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 to the FDA was supported by data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone treatment, showing symptom relief as early as 24 hours after administration and lasting for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike other antidepressants that primarily adjust levels of serotonin and dopamine in the brain, Spravato functions by increasing glutamate levels. Glutamate is the brain’s most prevalent neurotransmitter and plays a crucial role in neuron communication.
Sales of Spravato surged by 60%, reaching $271 million for the three-month period ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reports that the medication has been utilized by 100,000 patients across 77 countries.