Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, allowing it to be used as a standalone treatment for patients with treatment-resistant depression.
The FDA initially approved Spravato in 2019 as part of a combination therapy with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
The company highlighted that around 30 percent of the approximately 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the 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, leading to significant functional and emotional burdens for them and their families.”
The application for expanded usage is supported by data from a late-stage clinical trial, which demonstrated that Spravato, when used alone, can alleviate patients’ symptoms as quickly as 24 hours after treatment and maintain those effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a medical facility. Unlike traditional antidepressants that primarily affect serotonin and dopamine levels in the brain, Spravato enhances glutamate, the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same time frame in 2023. The medication has already been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.