Johnson & Johnson announced on Monday that it has applied to the U.S. Food and Drug Administration (FDA) for approval to expand the use of its ketamine-based drug, Spravato, to be used as a standalone treatment for individuals with treatment-resistant depression.
Originally approved in 2019, Spravato is currently used in combination with an oral antidepressant for patients who do not respond to two or more standard antidepressants. Johnson & Johnson noted that nearly 30% of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges that patients face, stating, “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 for expanded use is supported by data from a late-stage clinical trial, which indicated that Spravato, when administered alone, alleviated symptoms within 24 hours of treatment and sustained improvements for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider. Unlike traditional antidepressants that often target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels, the brain’s most prevalent neurotransmitter.
Sales of Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that Spravato has been utilized by 100,000 patients across 77 countries.