Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, to serve as a standalone treatment for individuals with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients whose symptoms remained unaddressed despite trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized that many patients dealing with difficult-to-treat depression often spend excessive time navigating through various treatments that fail to alleviate their symptoms, which imposes significant emotional and functional difficulties on both patients and their families.
The application included data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, was effective in reducing patients’ symptoms as early as 24 hours post-treatment, with improvement lasting for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional within a clinical environment. Unlike traditional antidepressants, which typically target brain chemicals such as serotonin and dopamine, Spravato acts by enhancing glutamate levels in the brain, a critical neurotransmitter for neuron communication.
Sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2022. To date, the medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.