Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for individuals whose symptoms persist after trying at least two different antidepressants. Johnson & Johnson highlighted that 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, expressed concern over the difficulties faced by patients enduring challenging-to-treat depression. He noted that many individuals often undergo long periods trying various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional burdens for both patients and their families.
The recent application to the FDA is supported by data from a late-stage clinical trial indicating that Spravato, when administered alone, could alleviate symptoms within 24 hours and maintain effectiveness over at least four weeks. This nasal spray treatment is designed to be given under the supervision of a healthcare professional. Unlike typical antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is vital for neuron communication.
In the second quarter of 2023, Spravato’s sales surged by 60%, reaching $271 million, a strong indicator of its growing acceptance in the market. The drug has already been utilized by around 100,000 individuals across 77 countries.
This development signifies a hopeful advancement in mental health treatment options for those who have exhausted traditional antidepressant therapies, potentially providing a more effective alternative for millions struggling with depression. As Johnson & Johnson continues to innovate in this space, the potential for improving patients’ quality of life remains promising.