Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based drug Spravato, allowing it to be used as a standalone treatment for individuals suffering from treatment-resistant depression.
Spravato was originally approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose depressive symptoms did not improve despite trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals worldwide diagnosed with major depressive disorder experience treatment-resistant depression.
“Many patients with difficult-to-treat depression endure prolonged periods trying numerous treatments that often fail to alleviate their symptoms, resulting in significant emotional and functional challenges for them and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The application to the FDA is backed by data from a late-stage clinical trial indicating that Spravato, when used alone, can alleviate symptoms in patients as quickly as 24 hours post-treatment, and effects can last for at least four weeks.
Spravato is delivered as a nasal spray and must be administered in a healthcare setting under the supervision of a medical professional. Unlike traditional antidepressants that target neurotransmitters such as serotonin and dopamine, Spravato enhances the activity of glutamate, the most prevalent neurotransmitter in the brain, which facilitates communication between neurons.
Sales of Spravato experienced a 60% increase, reaching $271 million in the quarter ending June 30, compared to the same period in 2022. According to Johnson & Johnson, Spravato has been utilized by 100,000 individuals across 77 countries.