Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressant medications.
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, head of neuroscience at Johnson & Johnson, emphasized the importance of this advancement, noting that patients often endure long periods of ineffective treatments, which can significantly impact their emotional well-being and the well-being of their loved ones.
The application for expanded use is supported by data from a late-stage clinical trial that demonstrated Spravato’s effectiveness as a standalone therapy, with some patients experiencing symptom relief as quickly as 24 hours after treatment, lasting for at least four weeks.
Spravato is administered through a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that focus on adjusting serotonin and dopamine levels in the brain, Spravato operates by increasing glutamate, the brain’s most prevalent neurotransmitter, facilitating better communication between neurons.
Sales for Spravato saw a remarkable increase of 60%, reaching $271 million for the quarter ending June 30 compared to the same period in 2023. The treatment has been employed by around 100,000 individuals across 77 countries, reflecting its growing acceptance and potential to help those in need.
This initiative marks a significant step forward in mental health treatment, potentially offering new hope to those struggling with the burdens of treatment-resistant depression. As more patients gain access to effective therapies, the outlook for mental health care continues to improve, underscoring the importance of ongoing research and innovation in this field.