Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, allowing it to be prescribed as a standalone treatment for patients with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially indicated for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants.
Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million people worldwide who suffer from major depressive disorder experience treatment-resistant depression. “Many patients enduring difficult-to-treat depression often spend excessive time trying various treatments that fail to address their symptoms, leading to significant functional and emotional strain on both themselves and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson.
The company’s application includes data from a late-stage clinical trial which demonstrated that Spravato, when used as a standalone treatment, alleviated symptoms in patients as soon as 24 hours after administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and is required to be taken under medical supervision. Unlike typical antidepressants that modify chemicals like serotonin and dopamine, Spravato increases levels of glutamate, the most prevalent neurotransmitter in the brain, facilitating communication between neurons.
Sales of 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, as reported by Johnson & Johnson.