Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the indication for its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, 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 is backed by data from a late-stage clinical trial that indicated Spravato, used as a standalone treatment, led to symptom relief for patients as early as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that primarily target chemicals like serotonin and dopamine, Spravato functions by enhancing the levels of glutamate in the brain, which is the most prevalent neurotransmitter and is crucial for neuronal communication.
Sales of Spravato increased by 60% to $271 million in the three-month period 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.