Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved in 2019, Spravato was designed to be used alongside an oral antidepressant for patients who did not see improvement after trying two or more antidepressants. According to Johnson & Johnson, approximately 30 percent of the estimated 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients with hard-to-treat depression, stating that many spend excessive time trying various treatments that fail to alleviate their symptoms, which can lead to significant emotional and functional burdens on both patients and their families.
The submission to the FDA was backed by data from a late-stage clinical trial, revealing that Spravato, when used as a standalone treatment, provided symptom relief as early as 24 hours after administration and sustained improvement for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target chemicals like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and crucial for neuronal communication.
Sales of Spravato experienced a remarkable 60% increase, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. Johnson & Johnson reported that the medication has been utilized by around 100,000 individuals across 77 countries.