Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, for treating resistant depression as a standalone therapy.
Spravato was initially approved by the FDA in 2019 but was limited to use alongside oral antidepressants for patients who did not respond to two or more antidepressant treatments.
The company highlighted that nearly 30 percent of the 280 million individuals globally diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients grappling with difficult-to-treat depression often endure lengthy periods trying multiple treatments that fail to alleviate their symptoms, resulting in significant emotional and functional burdens for themselves and their families.
The application was supported by results from a late-stage clinical trial indicating that Spravato as a standalone treatment could alleviate patients’ symptoms as quickly as 24 hours post-treatment, maintaining relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants which target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, a key neurotransmitter that facilitates neuron communication.
Sales for Spravato surged by 60% to reach $271 million during the quarter ending June 30, compared to the same timeframe in 2023. According to Johnson & Johnson, the drug has been utilized by 100,000 patients across 77 countries.