Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, to serve 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, targeting patients whose conditions did not improve with at least two different antidepressants. Johnson & Johnson highlighted that nearly 30% of the approximately 280 million individuals worldwide who suffer from 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 backed by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, could alleviate patients’ symptoms within 24 hours of administration and provide relief for at least four weeks.
Spravato is delivered via a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, facilitating neuronal communication.
In the second quarter of the year, sales of Spravato surged by 60%, reaching $271 million compared to the same period in 2023. The drug has been administered to approximately 100,000 patients across 77 countries, per Johnson & Johnson’s reporting.