Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in combination with an oral antidepressant for patients whose symptoms did not respond to at least two other antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
“Many patients dealing with difficult-to-treat depression endure lengthy periods cycling through various treatments that do not effectively alleviate their symptoms, leading to significant emotional and functional burdens for both the patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The recent application is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, can alleviate symptoms as soon as 24 hours after administration and sustain improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that primarily target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the predominant neurotransmitter and plays a key role in neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. The drug has been utilized by 100,000 patients across 77 countries, as reported by Johnson & Johnson.