Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, for treatment-resistant depression as a standalone therapy.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants. Johnson & Johnson noted that nearly 30 percent of the approximately 280 million people worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with hard-to-treat depression. He highlighted that many of these individuals spend excessive time trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional burdens.
The application for expanded use of Spravato was supported by data from a late-stage clinical trial, which indicated that the drug significantly alleviated patients’ symptoms as soon as 24 hours after treatment and maintained its effectiveness for at least four weeks.
Spravato is administered as a nasal spray and requires supervision by a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato increases glutamate levels, the most prevalent neurotransmitter in the brain, facilitating better communication between neurons.
Sales of Spravato surged by 60% to $271 million in the three months leading up to June 30, compared to the same period in the previous year. According to Johnson & Johnson, the drug has been utilized by 100,000 patients across 77 countries.