Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for patients with 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, 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 was supported by data from a late-stage clinical trial that demonstrated Spravato, when used as a standalone treatment, alleviated patients’ symptoms within 24 hours of treatment and sustained the improvement 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 clinical setting. Unlike typical antidepressants that adjust chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the primary neurotransmitter facilitating communication between neurons.
Sales of Spravato experienced a 60% increase, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been employed by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.