Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, to serve as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was intended to be combined with an oral antidepressant for patients whose symptoms did not respond to two or more antidepressants. Approximately 30 percent of the estimated 280 million individuals worldwide who suffer from major depressive disorder have treatment-resistant depression, according to the company.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application was supported by data from a late-stage clinical trial which indicated that Spravato, when used as an independent treatment, could alleviate patients’ symptoms as soon as 24 hours following administration and sustain this effect for at least four weeks.
Spravato is delivered via a nasal spray and must be administered under a healthcare provider’s supervision in a clinical setting. Unlike traditional antidepressants that primarily target serotonin and dopamine levels in the brain, Spravato functions by enhancing glutamate activity, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales for Spravato saw a remarkable increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.