Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019, but only for use alongside an oral antidepressant in patients who had not found relief after trying two or more antidepressants. According to Johnson & Johnson, around 30 percent of the approximately 280 million individuals globally diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by patients dealing with hard-to-treat depression, stating, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application for expanded use is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, demonstrated significant symptom relief for patients as early as 24 hours after administration and maintained this effect for at least four weeks.
Spravato is delivered as a nasal spray that must be administered under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato functions by enhancing glutamate activity in the brain, which is the predominant neurotransmitter aiding neuronal communication.
In terms of financial performance, sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the corresponding period in 2023. Johnson & Johnson reported that Spravato has been utilized by 100,000 patients across 77 countries.