Johnson & Johnson announced on Monday that it has applied to the U.S. Food and Drug Administration (FDA) for approval to use its ketamine-based drug, Spravato, as a standalone treatment for adults with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms remained unmanageable despite trying two or more antidepressant medications.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression. Bill Martin, the company’s head of neuroscience, stated in a press release, “Many patients enduring difficult-to-treat depression spend too long cycling through various treatments that fail to address their symptoms, placing a considerable functional and emotional strain on them and their families.”
The FDA application includes results from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, alleviated symptoms in patients as quickly as 24 hours post-treatment and sustained improvement for at least four weeks.
Spravato is administered via a nasal spray and is required to be taken under medical supervision in a healthcare setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate, the brain’s most abundant neurotransmitter, facilitating communication between neurons.
Sales for Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in the previous year. The drug has been utilized by 100,000 individuals across 77 countries, according to Johnson & Johnson.