Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, as a standalone therapy for individuals suffering from treatment-resistant depression. This marks a significant step forward in addressing the needs of patients who have not found relief from their symptoms through conventional antidepressant treatments.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with oral antidepressants for patients whose depression persisted despite trying two or more different antidepressants. Johnson & Johnson highlights that nearly 30 percent of the estimated 280 million people globally living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges that patients face when their depressive symptoms do not respond to available treatments. “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,” he stated.
The application to the FDA includes results from a late-stage clinical trial indicating that Spravato, when used alone, can alleviate symptoms within 24 hours and maintain effectiveness for at least four weeks. Spravato is administered via a nasal spray in a healthcare setting, and unlike traditional antidepressants that target serotonin and dopamine levels, it functions by enhancing glutamate activity, the most abundant neurotransmitter responsible for neuronal communication in the brain.
Sales of Spravato have experienced a remarkable increase of 60%, reaching $271 million for the quarter ending June 30, compared to the same period in the previous year. Since its launch, approximately 100,000 patients across 77 countries have utilized Spravato, underscoring its growing role in mental health treatment.
This development brings hope to many individuals struggling with treatment-resistant depression, potentially offering faster relief and improved quality of life. As Johnson & Johnson continues to innovate in the field of mental health, the potential expansion of Spravato’s use could represent a significant advancement in therapy options for those who need it most.