Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximate 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients facing difficult-to-treat depression spend excessive time cycling through various treatments that fail to alleviate their symptoms, leading to significant emotional and functional strain on both patients and their families,” stated Bill Martin, the head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, was effective in alleviating patients’ symptoms within 24 hours and continued to provide benefits for at least four weeks after treatment.
Spravato is delivered in a nasal spray form and must be administered under the supervision of a healthcare professional in a medical setting. In contrast to traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato acts by enhancing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in the previous year. The medication has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.