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-derived drug, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato received FDA approval in 2019 for use alongside an oral antidepressant for patients whose symptoms persisted despite trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide affected by major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression endure prolonged periods of trying various treatments that fail to alleviate their symptoms, causing significant emotional and functional distress for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application submission included findings from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, began to alleviate symptoms within 24 hours for some patients and maintained its effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical setting. Unlike traditional antidepressants that adjust neurotransmitters such as serotonin and dopamine, Spravato enhances levels of glutamate in the brain, which is the most prevalent neurotransmitter and crucial for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30 compared to the same quarter in 2023. Johnson & Johnson reports that Spravato has been utilized by 100,000 patients across 77 countries.