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 drug, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, 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 the challenges faced by patients, noting, “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 includes data from a late-stage clinical trial that demonstrated Spravato could alleviate symptoms within 24 hours, and remain effective for at least four weeks of treatment when used as a standalone option.
Spravato is administered through a nasal spray and must be used under the supervision of a healthcare provider in a clinical setting. Unlike other antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, the most prevalent neurotransmitter that facilitates communication between neurons.
Sales of Spravato increased by 60% in the three months leading up to June 30, reaching $271 million compared to the same period in 2023. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.