Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) aimed at expanding the approved use of its ketamine-based drug, Spravato, to allow it to be utilized as a standalone treatment for patients with treatment-resistant depression.
Spravato, which gained FDA approval in 2019, was initially authorized for use in conjunction with an oral antidepressant for individuals whose depression did not improve after trying two or more antidepressants. According to Johnson & Johnson, 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, emphasized the challenges many patients face, stating, “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 for expanded use of Spravato is backed by data from a late-stage clinical trial, which revealed that patients experienced symptom relief as early as 24 hours after treatment, with the effects lasting for at least four weeks. Spravato is administered as a nasal spray and requires supervision in a healthcare setting. Unlike traditional antidepressants that target serotonin and dopamine levels, Spravato works by enhancing glutamate activity in the brain, which is essential for effective neuron communication.
The financial success of Spravato is notable, reflecting a 60% increase in sales to $271 million for the quarter ending June 30, compared to the same period in 2023. To date, the drug has been used by approximately 100,000 individuals across 77 countries.
This submission to the FDA signifies a positive step forward for patients struggling with severe depression, potentially offering them a new avenue for treatment. The ongoing development and research into innovative treatment options like Spravato represent hope for those who have found little relief from conventional therapies.
In summary, Johnson & Johnson’s ongoing commitment to addressing mental health challenges through advanced therapeutic options illustrates a proactive approach to combatting treatment-resistant depression.