Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, to be used as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who did not see improvements after trying two or more antidepressants. About 30 percent of the estimated 280 million people globally suffering from major depressive disorder are believed to have treatment-resistant depression, according to Johnson & Johnson.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles of patients with hard-to-treat depression, stating that many endure a prolonged cycle of ineffective treatments, leading to significant emotional and functional burdens on both patients and their families.
The application includes data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, began alleviating symptoms within 24 hours and continued to do so for at least four weeks.
Spravato is administered as a nasal spray and is required to be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that typically regulate brain chemicals such as serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, which is crucial for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the second quarter, compared to the same period in 2023, with approximately 100,000 individuals in 77 countries having utilized the treatment, as reported by Johnson & Johnson.