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 medication, Spravato, allowing it to be administered as a standalone treatment for individuals with treatment-resistant depression.
The FDA initially approved Spravato in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms showed no improvement after trying two or more antidepressant medications. Johnson & Johnson highlighted that approximately 30 percent of the estimated 280 million people globally affected by major depressive disorder suffer from treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients with hard-to-treat depression, stating that they often experience prolonged periods trying multiple treatments that fail to alleviate their symptoms, leading to significant emotional and functional distress for both patients and their families.
The application submitted to the FDA is supported by data from a late-stage clinical trial demonstrating that Spravato, when used as a standalone treatment, provided symptom relief as early as 24 hours post-administration and maintained effectiveness for at least four weeks.
Spravato is delivered as a nasal spray and is required to be taken under the supervision of a healthcare professional in a clinical setting. Unlike traditional antidepressants that focus on regulating brain chemicals such as serotonin and dopamine, Spravato enhances glutamate activity in the brain. Glutamate is the brain’s most prevalent neurotransmitter, crucial for neuronal communication.
In financial terms, sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. Johnson & Johnson reports that Spravato has been utilized by 100,000 individuals across 77 countries.