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, so it can be utilized as a standalone therapy for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use in conjunction with an oral antidepressant for patients who did not experience improvements after trying two or more antidepressants.
Johnson & Johnson noted that nearly 30 percent of the approximately 280 million people globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, highlighted the plight of many patients who struggle with difficult-to-treat depression, stating that they often face lengthy periods of trialing ineffective treatments, leading to significant emotional and functional burdens on themselves and their families.
The application for expanding Spravato’s use is supported by data from a late-stage clinical trial indicating that the drug, when administered as a standalone treatment, can alleviate symptoms as quickly as 24 hours post-treatment and maintain effectiveness for at least four weeks thereafter.
As a nasal spray, Spravato must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that adjust serotonin or dopamine levels, Spravato functions by increasing levels of glutamate, the most prevalent neurotransmitter in the brain that facilitates communication between neurons.
Sales of Spravato experienced a remarkable 60% increase, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.