Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved usage of its ketamine-derived medication, Spravato, for use as a standalone treatment for individuals with treatment-resistant depression.
Spravato received its initial FDA approval in 2019, allowing its use in conjunction with an oral antidepressant for patients who had not seen improvement after attempting two or more antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million individuals worldwide who suffer from major depressive disorder are affected by treatment-resistant depression.
“Many patients facing difficult-to-treat depression often spend excessive time cycling through various treatments that fail to alleviate their symptoms, resulting in a considerable functional and emotional toll on both themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application was based on data from a late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, could alleviate patients’ symptoms as quickly as 24 hours after administration and sustain this effect for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider within a medical facility. Unlike traditional antidepressants that primarily target serotonin and dopamine levels in the brain, Spravato functions by enhancing the levels of glutamate, the brain’s most prevalent neurotransmitter, which facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same timeframe in 2023. The medication has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.