Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the usage of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019, permitting its use in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressant medications. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million people globally who suffer from major depressive disorder are affected by treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients struggling with difficult-to-treat depression often endure a lengthy ordeal of switching through various treatments that fail to alleviate their symptoms, placing a substantial emotional and functional strain on them and their families.
The application for Spravato’s expanded use was supported by data from a late-stage clinical trial which indicated that the drug, when used alone, significantly alleviated patients’ symptoms as early as 24 hours after administration, with effects lasting for a minimum of four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike conventional antidepressants that alter brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, being the most prevalent neurotransmitter, plays a crucial role in neuron communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2022. Johnson & Johnson reported that the medication has been utilized by approximately 100,000 individuals across 77 countries.