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-derived medication, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who have not found relief from two or more antidepressants. Approximately 30 percent of the estimated 280 million people worldwide diagnosed with major depressive disorder experience treatment-resistant depression, according to Johnson & Johnson.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized in a press release that many individuals grappling with difficult-to-treat depression often cycle through numerous ineffective treatments, leading to considerable functional and emotional strain on both themselves and their families.
The submission is backed by data from a late-stage clinical trial demonstrating that Spravato, when used alone, can alleviate symptoms in patients as quickly as 24 hours after administration and maintain effectiveness for at least four weeks of treatment.
Spravato is delivered via nasal spray and is required to be administered under the oversight of a healthcare professional in a clinical environment. Unlike traditional antidepressants that modify brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and essential for neuronal communication.
Sales of Spravato surged by 60% to reach $271 million in the three months ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the medication has been used by 100,000 people across 77 countries.