Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved uses of its ketamine-based medication, Spravato, to allow it to be administered as a standalone therapy for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals worldwide with major depressive disorder experience treatment-resistant depression.
“Many patients struggling with difficult-to-treat depression spend excessive time navigating through numerous treatments that fail to alleviate their symptoms, leading to considerable emotional and functional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson.
The application for expanded use was supported by data from a late-stage clinical trial, which indicated that Spravato could alleviate symptoms in patients as soon as 24 hours after administration, maintaining effects for at least four weeks.
Spravato is delivered as a nasal spray and must be taken in a healthcare setting under the supervision of a healthcare provider. Unlike other antidepressants that target chemicals like serotonin and dopamine, Spravato’s mechanism works by increasing glutamate levels in the brain, a neurotransmitter crucial for neuronal communication.
Sales for Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.