Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based treatment, Spravato, to function as a standalone therapy for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms had not improved with two or more antidepressants. Johnson & Johnson indicated that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients facing difficult-to-treat depression often endure prolonged periods trying various treatments without relief, which can place considerable emotional and functional strain on both patients and their families.
The application to the FDA was backed by data from a late-stage clinical trial that found Spravato, when used as a standalone therapy, could alleviate symptoms as soon as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Administered via nasal spray, Spravato must be used under healthcare provider supervision in a clinical setting. Unlike traditional antidepressants that modify the levels of chemicals such as serotonin and dopamine in the brain, Spravato enhances glutamate levels. Glutamate, the most prevalent neurotransmitter, plays a crucial role in neuronal communication.
Sales of Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same period in 2023. The treatment has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.