Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, to function as a standalone treatment for treatment-resistant depression.
The FDA initially approved Spravato in 2019, allowing it to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients with difficult-to-treat depression, noting that many often undergo prolonged periods trying multiple ineffective treatments, which can lead to significant emotional and functional hardships for them and their families.
The company’s application is based on results from a late-stage clinical trial demonstrating that Spravato, when used as a standalone therapy, alleviated symptoms in patients as early as 24 hours after treatment, maintaining these effects for at least four weeks.
Spravato is delivered via nasal spray and is required to be administered in a healthcare setting under professional supervision. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato acts by enhancing glutamate levels, which is the most prevalent neurotransmitter in the human brain and facilitates communication between neurons.
In terms of financial performance, sales for Spravato surged by 60% to $271 million in the second quarter, compared to the same time frame in 2023. According to Johnson & Johnson, the drug has been utilized by 100,000 patients across 77 countries.