Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who have not seen improvement after trying two or more other antidepressants. Johnson & Johnson noted that nearly 30 percent of the 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the pressing issue, 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 significant functional and emotional burden on patients and their loved ones.”
The FDA application was supported by data from a late-stage clinical trial demonstrating that Spravato, when used alone, alleviated symptoms in patients as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that act on serotonin and dopamine, Spravato enhances glutamate levels in the brain, a crucial neurotransmitter for neuronal communication.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been prescribed to 100,000 patients across 77 countries, according to Johnson & Johnson.