Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients who failed to find relief from two or more antidepressant medications. Johnson & Johnson noted that nearly 30% of the approximately 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, stating that many endure extended periods of trying various treatments with limited success, which can lead to significant emotional and functional burdens for both patients and their families.
The application was supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, alleviated symptoms within 24 hours and sustained relief for at least four weeks.
Spravato is administered as a nasal spray and must be dispensed under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that focus on regulating neurotransmitters like serotonin and dopamine, Spravato enhances glutamate, the brain’s most prevalent neurotransmitter, facilitating communication among neurons.
In financial terms, sales of Spravato experienced a 60% increase, reaching $271 million during the three-month period ending June 30, compared to the same timeframe in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to the company.