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, to function as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not see improvement after trying two or more different antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide suffering 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 company’s application is supported by data from a late-stage clinical trial that demonstrated Spravato as a standalone treatment alleviated patients’ symptoms as quickly as 24 hours post-treatment and maintained efficacy for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike typical antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato increased by 60%, reaching $271 million for the quarter that ended on June 30, compared to the same period in 2022. According to Johnson & Johnson, Spravato has been utilized by 100,000 individuals across 77 countries.