Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients whose symptoms persisted after using two or more other antidepressants. The company noted that nearly 30 percent of the estimated 280 million individuals around the world suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, Head of Neuroscience at Johnson & Johnson, expressed in a press release that many patients struggling with hard-to-treat depression often go through numerous treatments without finding effective relief, leading to considerable emotional and functional challenges for both themselves and their families.
The application for expanded use has been backed by data from a late-stage clinical trial, which indicated that Spravato, used by itself, could alleviate symptoms in patients as soon as 24 hours after treatment and maintain its effectiveness 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 that mainly affect serotonin and dopamine levels in the brain, Spravato enhances glutamate—a prevalent neurotransmitter that facilitates neuron communication.
Sales of Spravato reached $271 million for the quarter ending June 30, marking a 60% increase compared to the same period in 2023. According to Johnson & Johnson, the drug has been used by 100,000 patients across 77 countries.