Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to extend the approved use of its ketamine-based medication, Spravato, as a standalone treatment for those suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients whose symptoms were unresponsive to two or more traditional antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally who deal with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the plight of patients with difficult-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 is backed by results from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered through a nasal spray and requires administration under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that regulate neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication among neurons.
Sales for Spravato surged by 60% to $271 million during the three-month period ending June 30, compared to the same time frame in 2023. The drug has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.