Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to extend the approved use of its ketamine-based drug, Spravato, as a standalone treatment for patients with treatment-resistant depression.
Originally approved by the FDA in 2019, Spravato was initially intended to be used alongside an oral antidepressant for individuals whose conditions did not improve after trying two or more antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people globally who suffer from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients with difficult-to-treat depression, stating that many endure long periods of ineffective treatments, resulting in significant emotional and functional burdens for both patients and their families.
The application to the FDA is based on data from a late-stage clinical trial that indicated Spravato, when used as a standalone therapy, alleviated symptoms in patients in as little as 24 hours and maintained effectiveness for at least four weeks.
Spravato is delivered through a nasal spray and must be administered under medical supervision. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and essential for neuron communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2023. According to Johnson & Johnson, 100,000 people have utilized Spravato across 77 countries.