Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based drug, Spravato. The company seeks to allow Spravato to be administered as a standalone therapy for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used alongside an oral antidepressant for patients whose symptoms failed to improve after trying two or more different antidepressants.
Johnson & Johnson stated that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges these patients face. He noted that they often endure prolonged periods cycling through multiple ineffective treatments, which can put significant emotional and functional strain on both the patients and their families.
The application for Spravato was backed by data from a late-stage clinical trial, which demonstrated that the drug could reduce symptoms as soon as 24 hours post-treatment and continued to be effective for a minimum of four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical environment. Unlike conventional antidepressants that target chemical levels such as serotonin and dopamine, Spravato operates by increasing glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales figures reflect its growing acceptance, with revenues for Spravato jumping 60% to $271 million in the three months ending June 30, compared to the same quarter in 2023. To date, Spravato has been utilized by approximately 100,000 patients across 77 countries.