Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for those suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms failed to improve after using two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide diagnosed with 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 for expanded use was supported by data from a late-stage clinical trial indicating that Spravato, when administered as a standalone treatment, provided symptom relief as early as 24 hours and maintained effectiveness for at least four weeks.
Spravato is given as a nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike other antidepressants that primarily impact brain chemicals like serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, which is a crucial neurotransmitter responsible for neuron communication.
Sales of Spravato experienced a 60% increase, reaching $271 million in the three months leading up to June 30, compared to the same period in 2023. According to Johnson & Johnson, Spravato has been used by approximately 100,000 individuals across 77 countries.