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 medication, Spravato, to act as a standalone treatment for individuals suffering from treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in combination with an oral antidepressant for patients who had not seen improvements after trying two or more antidepressants.
Approximately 30 percent of the estimated 280 million individuals worldwide with major depressive disorder are believed to experience treatment-resistant depression, according to the company.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, stating that many often endure prolonged periods of trying various ineffective treatments, causing both functional and emotional distress for themselves and their families.
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, could alleviate patients’ symptoms as quickly as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that primarily affect serotonin and dopamine levels in the brain, Spravato acts by increasing glutamate levels, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato experienced a remarkable 60% increase, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.