Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggle faced by patients with difficult-to-treat depression, stating that many spend extended periods trying various treatments that often fail to alleviate their symptoms, resulting in significant emotional and functional challenges for both patients and their families.
The application for expanded use of Spravato is supported by data from a late-stage clinical trial, which indicated that as a standalone treatment, Spravato can begin to alleviate symptoms as soon as 24 hours after administration and continues to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under a healthcare provider’s supervision in a clinical environment. Unlike traditional antidepressants that primarily influence brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and crucial for neuronal communication.
In terms of performance, sales of Spravato surged by 60% to $271 million in the second quarter ended June 30, compared to the same timeframe in 2022. The medication has been prescribed to 100,000 patients across 77 countries, according to Johnson & Johnson.