Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the usage of its ketamine-derived medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose conditions did not improve despite trying two or more antidepressants.
The company noted that nearly 30 percent of the estimated 280 million individuals globally affected by major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression often spend extended periods cycling through various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional challenges for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The recent application includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone option, began to alleviate symptoms as soon as 24 hours post-treatment and maintained its effectiveness for a minimum of four weeks.
Spravato is delivered via a nasal spray and must be administered with the oversight of a healthcare provider in a clinical environment. Unlike conventional antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter in the brain and is essential for neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.