Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the approximately 280 million people worldwide living 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 to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used on its own, alleviated patients’ symptoms as quickly as 24 hours after administration, with sustained relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by increasing levels of glutamate, the brain’s most prevalent neurotransmitter, facilitating neuron communication.
Sales figures for Spravato saw a significant increase of 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2023. To date, Spravato has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.