Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone treatment for patients suffering from treatment-resistant depression.
The FDA originally approved Spravato in 2019 for use alongside an oral antidepressant for patients whose symptoms did not improve after trying two or more other antidepressants. Johnson & Johnson noted that nearly 30 percent of the approximately 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients dealing with difficult-to-treat depression, stating that many individuals endure long periods of trialing multiple treatments that fail to alleviate their symptoms. This can lead to significant emotional and functional challenges for both patients and their families.
The application to the FDA includes findings from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, could alleviate symptoms within 24 hours and maintain such effects for at least four weeks.
Spravato is administered via nasal spray and requires supervision by a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato functions by enhancing glutamate activity in the brain, which is the most prevalent neurotransmitter and plays a key role in neuron communication.
Sales figures reveal a 60% increase for Spravato, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. The treatment has been used by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.