Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Initially approved in 2019, Spravato was intended to be used in conjunction with an oral antidepressant for patients whose symptoms remained unaddressed by at least two other antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the difficulties faced by patients with tough-to-treat depression, noting that many experience prolonged periods of trying different therapies that fail to alleviate their symptoms, leading to significant emotional and functional challenges for both them and their families.
The latest application was supported by data from a late-stage clinical trial, indicating that Spravato, when used alone, can help alleviate symptoms as quickly as 24 hours after treatment and continue to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily affect serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is crucial for neuron communication.
Sales of Spravato surged by 60% to $271 million in the second quarter of 2023 compared to the same period the previous year. The medication has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.