Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, as a standalone therapy for patients suffering from treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use alongside an oral antidepressant in patients who had not seen improvement after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million individuals worldwide with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with hard-to-treat depression, stating that many endure prolonged periods of trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional strain on both themselves and their families.
The application for expanded use is supported by data from a late-stage clinical trial indicating that Spravato, used as a standalone treatment, can reduce patients’ symptoms within 24 hours and maintain effectiveness for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. In contrast to typical antidepressants that target neurotransmitters like serotonin and dopamine, Spravato increases the levels of glutamate, the brain’s most abundant neurotransmitter, which plays a crucial role in neuronal communication.
Sales of Spravato surged by 60% to $271 million for the quarter ending June 30 compared to the same period in the previous year. According to Johnson & Johnson, the drug has been utilized by approximately 100,000 individuals across 77 countries.