Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients who found no relief from their symptoms after trying two or more traditional antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the 280 million individuals worldwide with major depressive disorder suffer from treatment-resistant depression.
“Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” stated Bill Martin, head of neuroscience at Johnson & Johnson, emphasizing the urgent need for effective treatment options.
The application to the FDA is supported by data from a late-stage clinical trial, indicating that Spravato as a singular treatment can alleviate symptoms of depression as early as 24 hours post-administration and maintain efficacy for at least four weeks. Administered as a nasal spray, Spravato requires supervision by healthcare professionals during treatment. Unlike traditional antidepressants that function by regulating serotonin and dopamine levels, Spravato operates by increasing glutamate, the most abundant neurotransmitter, which plays a crucial role in communication between neurons.
In terms of financial performance, Spravato’s sales surged by 60% to reach $271 million for the three months ending June 30, compared to the same quarter last year. The product has already been utilized by around 100,000 individuals across 77 countries.
This promising development reflects Johnson & Johnson’s commitment to addressing severe mental health challenges and could pave the way for better outcomes for many individuals struggling with treatment-resistant depression. With the ongoing support for innovative therapies like Spravato, there remains hope for significant advancements in mental health treatment and a brighter future for patients seeking relief from their symptoms.