Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-derived drug, Spravato, to serve as a standalone therapy for treatment-resistant depression.
Initially approved in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose symptoms had not improved after trying two or more antidepressant medications. Johnson & Johnson noted that approximately 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
“In many cases, patients with hard-to-treat depression spend too long trying various treatments that fail to alleviate their symptoms, resulting in significant emotional and functional burdens for both them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The submission to the FDA includes data from a late-stage clinical trial that demonstrated Spravato’s efficacy as a standalone treatment, alleviating symptoms in patients as quickly as 24 hours after administration and maintaining relief for at least four weeks.
Spravato is administered via nasal spray and must be used under the supervision of a healthcare professional in a clinical setting. Unlike other antidepressants, which primarily target neurotransmitters like serotonin and dopamine, Spravato enhances the action of glutamate, the brain’s most prevalent neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60 percent, reaching $271 million in the quarter ending June 30, 2023, compared to the same period in the previous year. The drug is currently utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.