Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to approve its ketamine-based drug, Spravato, for use as a standalone therapy for patients with treatment-resistant depression. This marks a potential expansion of Spravato’s application, which was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals who did not find relief after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression. Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the urgent need for more effective treatment options, noting the emotional and functional toll that unresolved depression can take on patients and their families.
The submission for the new indication is backed by data from a late-stage clinical trial indicating that Spravato can alleviate symptoms as soon as 24 hours after administration and maintain its effects for at least four weeks. Notably, Spravato is administered as a nasal spray and must be used under medical supervision. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato leverages glutamate, the most prevalent neurotransmitter in the brain, to facilitate communication among neurons.
Additionally, sales of Spravato surged by 60% to $271 million in the second quarter of 2023, compared to the same period last year. The medication has already been utilized by around 100,000 patients across 77 countries.
This development presents a hopeful opportunity for those battling treatment-resistant depression, as it could lead to more effective and accessible treatment options for patients who have struggled to find relief through traditional therapies. As the medical community continues to explore innovative approaches to mental health, the potential for Spravato to offer timely relief highlights a positive step forward in addressing one of the more challenging aspects of mental health treatment.