Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based treatment, Spravato, to be utilized as a standalone therapy for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 as a treatment to be used alongside an oral antidepressant for individuals who did not see improvement with two or more other antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million individuals 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 included findings from a late-stage clinical trial, indicating that Spravato, used as a standalone treatment, positively affected patients’ symptoms as quickly as 24 hours after the treatment, continuing for a minimum of four weeks.
Spravato is delivered in a nasal spray format and must be administered under healthcare supervision. Unlike traditional antidepressants that influence serotonin and dopamine levels, Spravato enhances glutamate activity in the brain, aiding in neuron communication.
Sales for Spravato surged 60%, reaching $271 million in the quarter ending June 30 compared to the same period in 2022. The treatment has reached 100,000 patients across 77 countries, according to Johnson & Johnson.