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 medication, Spravato, allowing it to be administered as a standalone therapy for treatment-resistant depression.
Spravato received FDA approval in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants. The company highlighted that nearly 30 percent of the estimated 280 million individuals worldwide affected by major depressive disorder experience treatment-resistant depression.
“Many patients enduring difficult-to-treat depression often go through numerous ineffective treatments over extended periods, leading to significant emotional and functional burdens for both themselves and their families,” remarked Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was supported by findings from a late-stage clinical trial, indicating that Spravato, when used as a standalone treatment, was effective in alleviating symptoms within 24 hours and maintained improvement for at least four weeks.
Spravato is administered as a nasal spray and requires supervision by a healthcare professional in a medical setting. Unlike typical antidepressants, which alter serotonin and dopamine levels in the brain, Spravato enhances the action of glutamate, the brain’s most prevalent neurotransmitter, thereby facilitating communication between neurons.
In addition, Spravato’s sales surged by 60% to $271 million for the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the treatment has reached 100,000 users across 77 countries.