Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato is currently indicated for use in conjunction with an oral antidepressant for patients whose symptoms remain unmanageable after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release that many patients facing difficult-to-treat depression often go through numerous ineffective treatments, which can lead to considerable functional and emotional strain on both the patients and their families.
The FDA application is based on findings from a late-stage clinical trial, which demonstrated that Spravato, when used alone, alleviated patients’ symptoms as soon as 24 hours after administration and continued to do so for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that affect brain chemicals such as serotonin and dopamine, Spravato increases glutamate levels in the brain, which is essential for neuron communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. The drug has been utilized by around 100,000 individuals across 77 countries, as reported by Johnson & Johnson.