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 medication, Spravato, to serve as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms failed to improve despite trying two or more other antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with hard-to-treat depression, 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 submitted to the FDA is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, alleviated patients’ symptoms as soon as 24 hours after administration and sustained improvement for at least four weeks of treatment.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike other antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances levels of glutamate in the brain, which is the most prevalent neurotransmitter and is crucial for neuronal communication.
Sales of Spravato increased by 60% to reach $271 million in the quarter ending June 30, 2023, compared to the same time frame in the previous year. The medication has been utilized by around 100,000 patients across 77 countries, as reported by Johnson & Johnson.