Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the authorized use of its ketamine-based medication, Spravato, allowing it to be prescribed as a standalone treatment for patients suffering from treatment-resistant depression.
Spravato received FDA approval in 2019 for use alongside an oral antidepressant for individuals whose symptoms were unresponsive to two or more alternative antidepressants. Johnson & Johnson noted that nearly 30 percent of the estimated 280 million people worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized in a press release the challenges faced by patients enduring hard-to-treat depression, stating that many often endure prolonged periods trying different treatments that fail to alleviate their symptoms, leading to significant emotional and functional hardships for both patients and their families.
The application for expanded use was backed by results from a late-stage clinical trial indicating that Spravato, when used alone, can mitigate symptoms for patients as soon as 24 hours after treatment and maintain improvement for at least four weeks.
Administered as a nasal spray, Spravato requires administration under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that adjust levels of serotonin and dopamine, Spravato functions by enhancing glutamate in the brain, which is the most prevalent neurotransmitter facilitating communication between neurons.
Sales of Spravato surged by 60% to $271 million in the three-month period ending June 30, compared to the same quarter in 2022. The medication has been utilized by approximately 100,000 patients across 77 countries, according to Johnson & Johnson.