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 medication, Spravato, for use as a standalone treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was intended to be used alongside an oral antidepressant for individuals whose symptoms did not improve after trying two or more traditional antidepressants.
Johnson & Johnson indicated that nearly 30 percent of the approximately 280 million people globally affected by 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, highlighting the lengthy process of experimenting with various ineffective treatments, which can lead to significant emotional and functional burdens.
The company’s application to the FDA is supported by data from a late-stage clinical trial, demonstrating that Spravato, when used alone, alleviated symptoms in patients as soon as 24 hours post-treatment and maintained effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare setting under the supervision of a medical professional. Unlike many other antidepressants that affect neurotransmitters like serotonin and dopamine, Spravato enhances glutamate levels in the brain, the most prevalent neurotransmitter that facilitates communication between neurons.
Sales of Spravato saw a 60% increase, reaching $271 million in the quarter ending June 30, compared to the same timeframe in 2022. According to Johnson & Johnson, the drug has been utilized by 100,000 individuals across 77 countries.