Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato received its initial FDA approval in 2019, permitting its administration in tandem with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressant medications.
According to Johnson & Johnson, 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, emphasized the struggles faced by patients with hard-to-treat depression. He stated, “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 new application was backed by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours after treatment and maintained effectiveness for at least four weeks.
Spravato is administered as a nasal spray and requires supervision by a healthcare provider in a medical setting. Unlike traditional antidepressants that target chemicals like serotonin and dopamine, Spravato enhances the activity of glutamate, the brain’s most abundant neurotransmitter, facilitating communication between neurons.
Sales of Spravato experienced a remarkable increase of 60%, reaching $271 million in the three months ending June 30, compared to the same timeframe in 2023. The medication has been used by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.