Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for individuals with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose depression did not improve after taking two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the challenges faced by patients with difficult-to-treat depression, noting that many endure lengthy cycles of ineffective treatments, which can severely impact their functional and emotional well-being.
The application to the FDA was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate symptoms within 24 hours and continue to do so for a minimum of four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical facility. Unlike traditional antidepressants, which primarily target serotonin and dopamine levels in the brain, Spravato enhances glutamate activity. Glutamate is the most abundant neurotransmitter in the brain and plays a crucial role in neuronal communication.
Sales for Spravato surged by 60% to $271 million in the three-month period ending June 30, compared to the same timeframe in 2023. To date, the medication has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.