Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand 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 in conjunction with an oral antidepressant, specifically for patients whose symptoms did not improve after trying two or more traditional antidepressants.
According to Johnson & Johnson, nearly 30% of the estimated 280 million individuals worldwide dealing with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The recent application is backed by data from a late-stage clinical trial, which indicated that Spravato, when used alone, significantly alleviated patients’ symptoms as early as 24 hours after treatment and maintained effectiveness 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 standard antidepressants that affect neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter, facilitating communication between neurons.
Sales of Spravato experienced a 60% increase, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been utilized by 100,000 individuals across 77 countries, as reported by Johnson & Johnson.