Johnson & Johnson announced on Monday its submission of an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose symptoms failed to improve with two or more other medications. This latest application aims to provide an alternative for the approximately 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder who experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the need for effective treatments, 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 company’s application is bolstered by data from a late-stage clinical trial which indicated that Spravato, used as a standalone treatment, began alleviating symptoms within 24 hours and continued to be effective for at least four weeks. Administered as a nasal spray under medical supervision, Spravato differs from traditional antidepressants by increasing levels of glutamate, the brain’s most abundant neurotransmitter, thereby enhancing neuronal communication.
Sales of Spravato saw a substantial increase of 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2023. The medication has already been utilized by over 100,000 individuals across 77 countries.
This development could potentially lead to quicker and more effective treatment options for those struggling with severe depression, indicating a hopeful advancement in mental health therapies.
Summary: Johnson & Johnson has applied for FDA approval to expand the use of Spravato for treating treatment-resistant depression, based on promising clinical trial results. The drug showed quick symptom relief and has gained significant sales momentum, reflecting a growing recognition of its potential benefits in mental health treatment.