Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) to expand the approved use of its ketamine-based medication, Spravato, to serve as a standalone therapy for treatment-resistant depression.
Originally approved in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more antidepressants, Spravato targets a significant need in the mental health field. According to Johnson & Johnson, nearly 30% of the estimated 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted the struggles faced by patients dealing with difficult-to-treat depression. He noted that many suffer for extended periods, trying multiple treatments that fail to alleviate their symptoms, leading to both functional and emotional strain for them and their families.
The company’s application is based on data from a late-stage clinical trial indicating that Spravato, as a standalone treatment, can alleviate patients’ symptoms as soon as 24 hours after administration, with effects lasting at least four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato operates by enhancing glutamate levels in the brain, the most abundant neurotransmitter responsible for neuron communication.
In terms of sales, Spravato saw a remarkable increase of 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. Johnson & Johnson reported that approximately 100,000 patients in 77 countries have utilized Spravato.