Johnson & Johnson announced on Monday that it has requested approval from the U.S. Food and Drug Administration (FDA) to expand the use of their ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for patients suffering from treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson estimates that nearly 30 percent of the approximately 280 million people worldwide afflicted with major depressive disorder experience treatment-resistant depression.
“Many patients enduring difficult-to-treat depression go through prolonged periods trying various treatments that fail to alleviate their symptoms, causing significant emotional and functional burdens for both themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA was accompanied by data from a late-stage clinical trial demonstrating that Spravato, when used alone, could significantly relieve patients’ symptoms within as little as 24 hours, and sustain that relief for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances levels of glutamate, the brain’s most prevalent neurotransmitter that facilitates communication between neurons.
In financial terms, sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. According to Johnson & Johnson, Spravato has been utilized by 100,000 individuals across 77 countries.