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 drug, Spravato, allowing it to be used as a standalone therapy for treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use alongside an oral antidepressant for patients who did not experience improvement after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application to the FDA is based on data from a late-stage clinical trial that found Spravato as a standalone treatment alleviated patients’ symptoms as quickly as 24 hours after administration and continued to provide relief for at least four weeks of treatment.
Spravato is delivered as a nasal spray and must be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, the most prevalent neurotransmitter, facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million during the three months ending June 30, compared to the same period the previous year. Johnson & Johnson reported that the drug has been utilized by 100,000 individuals across 77 countries.