Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato, allowing it to be utilized as a stand-alone therapy for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose depressive symptoms did not improve after trying two or more antidepressants.
Johnson & Johnson noted that nearly 30 percent of the estimated 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by those with difficult-to-treat depression, stating that many patients endure lengthy periods trying various treatments that fail to alleviate their symptoms, leading to significant emotional and functional distress for both patients and their families.
The application submitted includes results from a late-stage clinical trial, which indicated that Spravato as a stand-alone treatment could alleviate patient symptoms as quickly as 24 hours post-treatment and maintain those benefits for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that modify neurotransmitters like serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, which is the predominant neurotransmitter and facilitates communication between neurons.
In the three months ending June 30, sales of Spravato surged by 60% to $271 million compared to the same period in 2023. The drug has been utilized by 100,000 individuals across 77 countries, according to the company.