Johnson & Johnson announced on Monday that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking to broaden the approved use of its ketamine-based medication, Spravato, to function as a standalone treatment for individuals with treatment-resistant depression.
Spravato was originally approved by the FDA in 2019 for use in combination with an oral antidepressant for patients whose symptoms failed to improve after trying two or more antidepressants. Johnson & Johnson estimates that around 30 percent of the approximately 280 million people worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized that many patients grappling with difficult-to-treat depression often endure lengthy periods trying out various treatments that do not effectively alleviate their symptoms, leading to significant emotional and functional distress for both patients and their families.
The application includes data from a late-stage clinical trial indicating that Spravato, used as a standalone treatment, can help relieve symptoms within 24 hours of administration and maintain effectiveness for at least four weeks.
Spravato is delivered via nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants, which typically focus on regulating neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the brain’s most abundant neurotransmitter, playing a crucial role in neuronal communication.
The sales of Spravato surged by 60%, reaching $271 million in the three months ending on June 30, compared to the same timeframe in 2023. According to Johnson & Johnson, the medication has been utilized by 100,000 individuals across 77 countries.