Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based medication, Spravato. The company aims for Spravato to be recognized as a standalone therapy for individuals suffering from treatment-resistant depression.
The FDA initially granted approval for Spravato in 2019, allowing its use in conjunction with an oral antidepressant for patients whose conditions did not improve after trying two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, 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 is backed by data from a recent late-stage clinical trial, which demonstrated that Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration, with effects lasting 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 adjust neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate activity, which is the most prevalent neurotransmitter in the brain and facilitates communication between neurons.
In the latest quarterly report, sales of Spravato witnessed a significant 60% increase, reaching $271 million for the three months ending June 30, compared to the same period in 2022. The medication has been utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.