Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based medication, Spravato, allowing it to be administered as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use alongside an oral antidepressant in patients whose symptoms did not improve after trying two or more other antidepressants.
The company highlighted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, Johnson & Johnson’s head of neuroscience, emphasized in a press release the challenges faced by patients with difficult-to-treat depression, stating that many endure lengthy periods trying multiple ineffective treatments, which significantly impacts their functionality and emotional well-being.
The application to the FDA is supported by data from a late-stage clinical trial indicating that Spravato, when used alone, can alleviate patients’ symptoms as soon as 24 hours post-treatment, lasting for at least four weeks.
Spravato is administered via nasal spray and must be taken under healthcare supervision. Contrary to many traditional antidepressants that target neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, the most prevalent neurotransmitter that facilitates communication between neurons.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reported that the medication has been utilized by 100,000 patients across 77 countries.