Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) for approval to expand the use of its ketamine-based drug, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million people worldwide who suffer from major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at the company, emphasized the struggles faced by these patients, stating that many spend significant time trying various treatments that fail to alleviate their symptoms, leading to both functional and emotional burdens for them and their families.
The application for expanded use relies on data from a late-stage clinical trial demonstrating that Spravato, when used alone, can begin to alleviate symptoms within 24 hours and continue to be effective for at least four weeks following treatment.
Administered as a nasal spray, Spravato must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is critical for neuronal communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30 compared to the same period in 2023. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.