Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, for treating resistant depression as a standalone therapy.
Initially approved by the FDA in 2019, Spravato is currently indicated to be used in conjunction with an oral antidepressant for patients whose symptoms do not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients struggling with difficult-to-treat depression often spend excessive time going through various treatments that fail to alleviate their symptoms, leading to significant emotional and functional challenges for them and their families.
The company’s application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, could begin to alleviate symptoms within 24 hours and maintain this improvement for at least four weeks.
Spravato is administered via a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain. Glutamate is the dominant neurotransmitter in the brain and is crucial for neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in the previous year. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.