Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to widen the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for treatment-resistant depression.
Spravato initially received FDA approval in 2019 for use alongside an oral antidepressant for patients whose depression did not respond to at least two different antidepressant therapies.
Approximately 30% of the 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression, according to the company.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients with difficult-to-treat depression, explaining that they often spend excessive time trying multiple treatments that fail to alleviate their symptoms, which can significantly impact their functionality and emotional well-being.
The application for expanded use is backed by data from a late-stage clinical trial, which indicated that Spravato as a standalone treatment could alleviate symptoms as quickly as 24 hours post-treatment and sustain these improvements for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under medical supervision in healthcare settings. Unlike traditional antidepressants that target chemicals like serotonin and dopamine, Spravato enhances glutamate functioning in the brain, which is the primary neurotransmitter facilitating neuronal communication.
In the three months ending June 30, sales of Spravato surged by 60% to $271 million compared to the same period in the previous year. The medication has been utilized by around 100,000 individuals across 77 countries, according to Johnson & Johnson.