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 administered as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in combination with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent 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 faced by patients with difficult-to-treat depression, stating that many spend excessive time trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional burdens for both patients and their families.
The application to the FDA is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, can relieve patients’ symptoms as soon as 24 hours after treatment and maintain these improvements for at least four weeks.
Spravato is administered via nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, facilitating communication between neurons.
Sales of Spravato have seen a significant increase, rising 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the treatment has been utilized by around 100,000 individuals across 77 countries.