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 patients suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million people worldwide diagnosed with major depressive disorder experience treatment-resistant depression. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients dealing with difficult-to-treat depression, highlighting that many often go through numerous treatments that fail to alleviate their symptoms, which can create significant emotional and functional challenges for both patients and their families.
The company’s application to the FDA is backed by data from a late-stage clinical trial demonstrating that Spravato, when used alone, was effective in reducing symptoms as quickly as 24 hours after administration and continued to show benefits for at least four weeks.
Spravato is delivered as a nasal spray and requires administration under a healthcare professional’s supervision. Unlike traditional antidepressants that modify neurotransmitters such as serotonin and dopamine, Spravato enhances the levels of glutamate in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
In financial terms, sales of Spravato surged by 60%, reaching $271 million in the three-month period ending June 30, compared to the same timeframe in 2022. The medication has been utilized by approximately 100,000 patients across 77 countries, as reported by Johnson & Johnson.