Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) for the expansion of its ketamine-based medication, Spravato, to be utilized as a standalone therapy for patients with treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the estimated 280 million individuals globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the struggles faced by patients with difficult-to-treat depression, stating that many individuals spend excessive amounts of time attempting various treatments that do not effectively relieve their symptoms, leading to significant emotional and functional burdens on both patients and their families.
The application for Spravato as a standalone treatment is backed by data from a late-stage clinical trial, which demonstrated that it could alleviate patients’ symptoms as early as 24 hours post-treatment and maintain this improvement for at least four weeks.
Spravato is administered through a nasal spray, and its use must occur under the supervision of a healthcare professional in a clinical environment. Unlike other antidepressants that target brain chemicals such as serotonin and dopamine, Spravato enhances glutamate levels in the brain. Glutamate is the most prevalent neurotransmitter, playing a crucial role in neuronal communication.
In financial terms, sales of Spravato surged by 60%, reaching $271 million in the second quarter of 2023 compared to the same period in 2022. The medication has been utilized by approximately 100,000 patients across 77 countries, according to the company.