Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Originally approved by the FDA in 2019 for use alongside an oral antidepressant for individuals who did not respond to two or more antidepressants, Spravato is aimed at addressing a critical need as nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant cases, according to the company.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients enduring difficult-to-treat depression, stating that they often go through numerous ineffective treatments, resulting in significant emotional and functional distress for both themselves and their families.
The application to the FDA was supported by data from a late-stage clinical trial, indicating that Spravato, when used alone, demonstrated the ability to alleviate symptoms within 24 hours and maintained its effects for at least four weeks.
Spravato is delivered as a nasal spray and is required to be administered in a healthcare setting under professional supervision. Unlike traditional antidepressants that primarily target serotonin and dopamine levels, Spravato enhances glutamate levels, which is the brain’s most prevalent neurotransmitter and plays a key role in neuronal communication.
In financial performance, sales of Spravato surged by 60% to reach $271 million in the quarter ended June 30, compared to the same period in 2023, with approximately 100,000 users across 77 countries reported by Johnson & Johnson.