Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved usage of its ketamine-based drug, Spravato, allowing it to be used as a standalone treatment for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designated for use in conjunction with oral antidepressants for patients whose symptoms failed to respond to two or more other antidepressants.
Johnson & Johnson reported that nearly 30 percent of the approximately 280 million people worldwide suffering from major depressive disorder have treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, highlighted in a press release the challenges faced by patients with difficult-to-treat depression, stating, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The company’s application to the FDA is supported by data from a late-stage clinical trial, which indicated that Spravato, when used as a stand-alone therapy, provided symptom relief to patients as early as 24 hours following treatment and sustained improvement for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances glutamate levels in the brain, which is the most prevalent neurotransmitter and plays a crucial role in neuronal communication.
Sales of Spravato rose significantly in the last quarter, climbing 60% to $271 million compared to the same period last year. The medication has been used by 100,000 individuals across 77 countries, according to the company.