Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based drug, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
Spravato received its initial FDA approval in 2019 for use alongside an oral antidepressant for patients whose symptoms failed to improve after trying two or more antidepressants.
According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release that many patients dealing with difficult-to-treat depression often go through numerous ineffective treatments, which can lead to significant emotional and functional distress for both them and their loved ones.
The company’s application 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 and maintain that relief for a minimum of four weeks.
Spravato is delivered via a nasal spray and must be administered under the supervision of a healthcare provider in a medical setting. Unlike traditional antidepressants that target brain chemicals like serotonin and dopamine, Spravato enhances glutamate levels in the brain, a key neurotransmitter that aids neuron communication.
Sales of Spravato surged by 60% to $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reports that the drug has been utilized by 100,000 patients across 77 countries.