Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant targeted at patients whose symptoms did not improve after trying two or more other antidepressant medications.
According to Johnson & Johnson, nearly 30% of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients with hard-to-treat depression often spend too much time cycling through various treatments that fail to alleviate their symptoms, imposing a significant emotional and functional toll on both themselves and their families.
The application to the FDA included results from a late-stage clinical trial, which indicated that Spravato as a standalone treatment could alleviate patients’ symptoms as early as 24 hours post-treatment and continue to do so for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike typical antidepressants that target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, a crucial neurotransmitter that facilitates neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. The medication has been prescribed to 100,000 patients across 77 countries, according to the company.