Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that “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 was supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after the initial treatment and continued to do so for at least four weeks.
Spravato is administered as a nasal spray under the supervision of a healthcare provider in a clinical setting. Unlike many other antidepressants that modulate chemicals such as serotonin and dopamine in the brain, Spravato enhances glutamate levels, the most prevalent neurotransmitter that facilitates communication between neurons.
In terms of sales, Spravato experienced a remarkable 60% increase to $271 million in the three-month period ending June 30, compared to the same timeframe in 2023. To date, Spravato has been used by 100,000 individuals in 77 countries, as reported by Johnson & Johnson.