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 medication, Spravato. The company aims for Spravato to be recognized as a standalone therapy for individuals battling treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressant medications. Johnson & Johnson highlighted that nearly 30 percent of the 280 million people worldwide living 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 application to the FDA includes data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, provided symptom relief as early as 24 hours post-treatment and maintained this 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 target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, 2023. The medication has been utilized by 100,000 patients across 77 countries, according to Johnson & Johnson.