Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose condition did not improve after trying two or more antidepressants.
According to Johnson & Johnson, approximately 30 percent of the 280 million people globally living with major depressive disorder suffer from treatment-resistant depression. “Many patients grappling with difficult-to-treat depression endure long periods trying multiple treatments that fail to alleviate their symptoms, resulting in significant emotional and functional distress for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson.
The application was supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, showed the capability to alleviate patients’ symptoms as quickly as 24 hours after administration and maintained efficacy for at least four weeks.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that primarily target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and is crucial for neuronal communication.
Sales of Spravato saw a remarkable increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been administered to 100,000 individuals across 77 countries, according to Johnson & Johnson.