Johnson & Johnson announced on Monday that it has submitted a new application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based medication, Spravato, to function as a standalone treatment for individuals suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was authorized for use in conjunction with an oral antidepressant for patients who did not experience relief from two or more conventional antidepressants. Johnson & Johnson reported that nearly 30 percent of the estimated 280 million individuals worldwide living with major depressive disorder are affected by treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the urgent need for effective treatment options, stating that many patients with difficult-to-treat depression endure lengthy cycles of ineffective treatments, which not only impact their well-being but also place a significant emotional strain on their families.
The FDA application includes data from a late-stage clinical trial indicating that Spravato, when used independently, can alleviate depressive symptoms in as little as 24 hours and maintain its effects for at least four weeks post-treatment. Unlike traditional antidepressants that primarily alter the levels of serotonin and dopamine, Spravato increases glutamate levels—an essential neurotransmitter involved in neuronal communication.
In financial terms, Spravato’s sales witnessed an impressive growth of 60%, reaching $271 million for the quarter ending June 30, 2023, compared to the same period in the previous year. The medication has already been utilized by approximately 100,000 individuals across 77 countries.
The potential for Spravato to serve as a standalone treatment brings a glimmer of hope to many suffering from treatment-resistant depression. As awareness and acceptance of mental health issues continue to grow, the expansion of effective treatment options like Spravato could significantly improve the lives of millions struggling with this challenging condition.