Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, as a standalone treatment 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 did not see improvements after trying two or more antidepressants.
The company highlighted that nearly 30 percent of the 280 million individuals globally living with major depressive disorder experience treatment-resistant depression, which presents significant challenges. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the distressing reality faced by these patients, stating, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, causing a significant functional and emotional burden.”
The application to the FDA is backed by data from a late-stage clinical trial showing that Spravato can alleviate symptoms in patients as soon as 24 hours after treatment and maintain this effect for at least four weeks. The medication is delivered as a nasal spray and must be administered under the supervision of a healthcare provider. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato operates by enhancing glutamate levels, the brain’s most plentiful neurotransmitter, thereby improving neural communication.
Sales figures for Spravato reflect its growing acceptance, with a remarkable 60% increase to $271 million in the quarter ending June 30 compared to the same period in 2023. The medication has already reached approximately 100,000 patients across 77 countries.
This advancement in the treatment landscape offers hope for those suffering from difficult-to-treat depression, potentially providing an effective new option for many seeking relief.
Overall, as the world continues to wrestle with mental health issues at unprecedented levels, innovations like Spravato bring a positive shift toward addressing these challenges and improving the quality of life for countless individuals.