Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, so it can be prescribed as a standalone treatment for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30% of the approximately 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, commented on the situation, stating that many patients dealing with difficult-to-treat depression often spend excessive time trying various treatments that fail to alleviate their symptoms, which can lead to significant emotional and functional distress for both patients and their families.
The application was supported by data from a recently conducted late-stage clinical trial that indicated Spravato, used as a standalone treatment, could begin alleviating symptoms as soon as 24 hours after administration and could provide relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by increasing levels of glutamate in the brain, which is the brain’s most prevalent neurotransmitter and is crucial for neuronal communication.
Sales for Spravato surged by 60%, reaching $271 million in the second quarter compared to the same period last year. The drug has been utilized by 100,000 individuals across 77 countries, according to the company.