Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based medication, Spravato, for use as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be administered in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, expressed in a press release that many patients endure prolonged struggles with ineffective treatments, which can impose a significant emotional and functional toll on them and their families.
The application was supported by results from a late-stage clinical trial demonstrating that Spravato, when administered alone, alleviated symptoms as quickly as 24 hours post-treatment and continued to provide relief for at least four weeks.
Spravato is delivered via nasal spray and must be taken under the supervision of a healthcare provider in a designated setting. Unlike traditional antidepressants that primarily target neurotransmitters like serotonin and dopamine, Spravato functions by enhancing glutamate levels in the brain, the most prevalent neurotransmitter that facilitates neuronal communication.
Sales of Spravato increased by 60% to $271 million in the quarter ending June 30, compared to the same period in 2022. The medication has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.