Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based drug, Spravato, so it can be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more traditional antidepressants.
The company noted that nearly 30 percent of the approximately 280 million individuals worldwide diagnosed with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, Johnson & Johnson’s head of neuroscience, 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 submission to the FDA includes findings from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, can alleviate symptoms as quickly as 24 hours after administration and continue to do so 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 other antidepressants that target brain chemicals such as serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate, the brain’s most prevalent neurotransmitter, plays a crucial role in neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three-month period ending June 30 compared to the same timeframe in 2022. Johnson & Johnson reported that the drug has been utilized by 100,000 individuals across 77 countries.