Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval to use its ketamine-based drug, Spravato, as a standalone treatment for resistant depression.
Spravato was first approved by the FDA in 2019 as a combination therapy alongside an oral antidepressant for patients whose symptoms did not improve with at least two other antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients with difficult-to-treat depression often spend excessive time trying different treatments that do not effectively alleviate their symptoms, which can place a considerable emotional and functional burden on them and those around them.
The application to the FDA was accompanied by data from a late-stage clinical trial demonstrating that Spravato, when used alone, could alleviate symptoms as early as 24 hours post-treatment and sustain improvement for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider. Unlike other antidepressants that primarily regulate brain chemicals like serotonin and dopamine, Spravato acts by increasing levels of glutamate, the brain’s most common neurotransmitter, which facilitates communication between neurons.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been utilized by over 100,000 individuals across 77 countries, according to the company.