Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the usage of its ketamine-based medication, Spravato, as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 to be used alongside an oral antidepressant for patients who did not see improvements after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges 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 application to the FDA includes findings from a late-stage clinical trial, which indicated that Spravato as a standalone treatment could alleviate symptoms in patients as quickly as 24 hours after administration, with effects lasting for at least four weeks.
Spravato is delivered through a nasal spray and must be administered under the supervision of a healthcare provider in a clinical environment. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, which is the most abundant 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 timeframe in 2023. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.