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 drug, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients who had not seen improvement after trying two or more different antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, stating that they often endure lengthy periods trying various treatments that fail to alleviate their symptoms, inflicting significant emotional and functional distress on both them and their families.
The submission to the FDA was supported by data from a recent late-stage clinical trial, which indicated that Spravato, when used alone, could alleviate symptoms in patients as quickly as 24 hours after administration and maintain effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and requires administration under the supervision of a healthcare provider in an appropriate setting. Unlike traditional antidepressants that primarily target serotonin and dopamine levels in the brain, Spravato enhances glutamate activity, which is the most prevalent neurotransmitter and plays a vital role in neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. Johnson & Johnson reported that the treatment has been utilized by 100,000 individuals across 77 countries.