Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be administered as a standalone therapy for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people globally affected by major depressive disorder experience treatment-resistant depression.
“Many patients enduring difficult-to-treat depression often spend an excessive amount of time trying various treatments that fail to alleviate their symptoms, which can impose a significant functional and emotional burden on them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, demonstrated symptom relief as quickly as 24 hours post-treatment and continued effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under the guidance of a healthcare provider in a clinical environment. Unlike other antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a critical role in neuronal communication.
Sales of Spravato have surged by 60%, reaching $271 million in the three months ending June 30, compared to the same period in 2023. According to Johnson & Johnson, Spravato has been utilized by 100,000 individuals across 77 countries.