Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to expand the use of its ketamine-based drug, Spravato, for use as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant in patients whose symptoms did not improve after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the approximately 280 million individuals worldwide who suffer 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. He stated that many of these patients spend considerable time trying multiple treatments that ultimately fail to alleviate their symptoms, contributing to significant emotional and functional burdens for themselves and their loved ones.
The application to the FDA is supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a standalone treatment, was able to reduce patients’ symptoms as quickly as 24 hours after administration and maintained efficacy for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a key role in neuron communication.
Sales of Spravato surged by 60%, reaching $271 million in the three-month period ending June 30, compared to the same timeframe in 2023. The drug has been utilized by around 100,000 individuals across 77 countries, according to Johnson & Johnson.