Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) seeking to expand the approved use of its ketamine-based drug, Spravato, to function 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 for patients who have not benefited from two or more antidepressants. Johnson & Johnson highlighted that nearly 30 percent of the estimated 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, Johnson & Johnson’s head of neuroscience, stated in a press release that many patients dealing with difficult-to-treat depression often spend excessive time trying various treatments that fall short of alleviating their symptoms, creating considerable functional and emotional challenges for both patients and their families.
The application was supported by data from a late-stage clinical trial that indicated Spravato, when used as a standalone treatment, alleviated patients’ symptoms as soon as 24 hours after administration and continued to do so for at least four weeks.
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 brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate, which is the most prevalent neurotransmitter in the brain, plays a crucial role in neuron communication.
Sales for Spravato surged by 60% to reach $271 million in the quarter ending June 30, compared to the same timeframe in 2022. The medication has been utilized by approximately 100,000 individuals across 77 countries, according to Johnson & Johnson.