Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato, to allow it to be administered as a standalone therapy for individuals suffering from treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve despite trying two or more other antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients, stating that many endure lengthy periods of trying various ineffective treatments, which can significantly impact their functionality and emotional well-being, as well as that of their families.
The application for the expanded use of Spravato relies on data from a late-stage clinical trial, which demonstrated that the drug could alleviate symptoms as quickly as 24 hours post-treatment and maintain efficacy for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate activity in the brain, a key neurotransmitter responsible for neuronal communication.
In a related financial update, sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30 compared to the same period in 2023. The medication has been utilized by approximately 100,000 individuals across 77 nations, according to Johnson & Johnson.