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 previously allowed for use in conjunction with an oral antidepressant in patients who did not respond to two or more antidepressant treatments. Johnson & Johnson noted that nearly 30 percent of the approximately 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients with difficult-to-treat depression, stating that many spend considerable time trying various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional burdens on both themselves and their families.
The application for expanded use is supported by data from a late-stage clinical trial, which demonstrated that Spravato, when used alone, could alleviate symptoms in patients as soon as 24 hours after treatment and maintain effectiveness for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that primarily influence chemicals like serotonin and dopamine, Spravato enhances glutamate, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
In financial terms, sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson reports that Spravato has been utilized by approximately 100,000 individuals across 77 countries.