Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, to serve as a standalone treatment for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant for patients who did not respond to two or more antidepressant medications.
The company pointed out that nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder are affected by treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression spend too long trying various treatments that fail to address their symptoms, leading to significant functional and emotional challenges for both the patients and their families,” said Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application for expanded use is supported by data from a late-stage clinical trial that indicated Spravato, when used alone, alleviated patients’ symptoms as quickly as 24 hours post-treatment and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the oversight of a healthcare provider in a clinical environment. Unlike traditional antidepressants that influence brain chemicals like serotonin and dopamine, Spravato acts by enhancing levels of glutamate, the brain’s most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato experienced a remarkable increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been utilized by 100,000 people across 77 countries.