Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) for the approval of its ketamine-based drug, Spravato, as a standalone treatment for treatment-resistant depression. This marks a significant step in providing new options for patients struggling with this condition.
Originally approved by the FDA in 2019, Spravato’s initial use was as an adjunct therapy, meant to be combined with oral antidepressants for individuals whose depression did not improve after trying two or more other antidepressants. This new application aims to offer a standalone alternative to the nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder who experience treatment-resistant symptoms.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the burden that these challenging-to-treat conditions place on patients and their families, noting that many endure lengthy periods of inadequate treatment. The clinical trial data submitted with the application indicates that Spravato can begin alleviating symptoms as swiftly as 24 hours after administration and remain effective for at least four weeks.
Spravato is administered as a nasal spray and requires supervision by a healthcare professional during its use. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato functions by increasing glutamate levels in the brain, a neurotransmitter vital for neuron communication.
The drug has seen substantial commercial success, with sales up by 60% to $271 million in the quarter ending June 30, compared to the same timeframe last year. It is estimated that 100,000 patients in 77 countries have benefited from Spravato, underscoring its growing acceptance and use.
This development not only reflects Johnson & Johnson’s commitment to addressing mental health challenges but also provides hope for those who have struggled to find relief from their depression. The potential approval of Spravato as a standalone treatment could pave the way for more effective and timely interventions for millions suffering from this debilitating condition.