Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato. The company aims for Spravato to be utilized as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not respond to two or more antidepressant therapies. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the struggle many patients face in finding effective treatment for their depression, stating that it often leads to prolonged suffering for both patients and their loved ones.
The application to the FDA was supported by data from a late-stage clinical trial that indicated Spravato could alleviate symptoms in patients as soon as 24 hours after treatment and maintain its effects for at least four weeks.
Spravato is administered as a nasal spray and is required to be given under the supervision of a healthcare provider in a clinical setting. Unlike conventional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, which is critical for neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30 compared to the same timeframe in 2023. The drug has been utilized by over 100,000 individuals across 77 countries, according to the company.