Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based drug, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially indicated for use in conjunction with an oral antidepressant for patients whose symptoms did not improve with two or more antidepressant treatments.
Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million people globally diagnosed with major depressive disorder suffer from 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 included data from a late-stage clinical trial, which demonstrated that Spravato as a standalone treatment provided symptom relief as quickly as 24 hours after administration and sustained improvement for at least four weeks.
Spravato is delivered via a nasal spray and requires administration under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that regulate neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, the most prevalent neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30, compared to the same period in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.