Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was meant to be used alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated in a press release, “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 to the FDA is backed by data from a late-stage clinical trial, which demonstrated that Spravato as a standalone treatment alleviated patients’ symptoms as quickly as 24 hours after treatment and maintained its effects for at least four weeks.
Spravato is administered as a nasal spray and must be taken in a healthcare setting under the supervision of a healthcare professional. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances the activity of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.