Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Spravato was first authorized by the FDA in 2019 as part of a treatment regimen alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally diagnosed with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that “many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, leading to significant functional and emotional burdens on patients and their families.”
The company’s application includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration and continued to be effective for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances levels of glutamate in the brain. Glutamate is the most prevalent neurotransmitter, essential for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. The product has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.