Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve with at least two other antidepressants. According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated that patients struggling with tough-to-treat depression often endure long periods trying multiple ineffective treatments, which can significantly impact their emotional and functional well-being.
The application to the FDA is backed by data from a late-stage clinical trial demonstrating that Spravato, when used alone, can alleviate symptoms as soon as 24 hours after treatment and continue to do so for a minimum of four weeks.
Administered via nasal spray, Spravato must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales figures indicate a robust demand for Spravato, which saw a 60% increase to $271 million in the second quarter compared to the same period in 2023. The drug has been utilized by approximately 100,000 patients across 77 countries, according to the company.