Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the usage of its ketamine-based medication, Spravato, as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a complementary treatment alongside an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“Many patients dealing with hard-to-treat depression spend too much time cycling through numerous treatments that fail to effectively alleviate their symptoms, leading to significant emotional and functional challenges for both them and their loved ones,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application for expanded use was supported by data from a late-stage clinical trial indicating that Spravato could alleviate patients’ symptoms as soon as 24 hours after administration and lasting at least four weeks.
Spravato is delivered via nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants, which typically target chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the brain’s most prevalent neurotransmitter, essential for neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period last year. According to Johnson & Johnson, the drug has been utilized by 100,000 individuals across 77 countries.