Johnson & Johnson announced on Monday that it has submitted a new application to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato. The new proposal seeks approval for Spravato to be utilized as a standalone therapy for individuals with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was meant to be used alongside an oral antidepressant for patients whose symptoms failed to improve despite trying multiple treatments. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million individuals globally suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, emphasized the plight of many patients enduring difficult-to-treat depression. He noted that these individuals often go through numerous ineffective treatments, resulting in significant emotional and functional challenges for themselves and their families.
The application to the FDA was bolstered by findings from a late-stage clinical trial, which indicated that Spravato could alleviate symptoms within 24 hours of treatment and maintain efficacy for at least four weeks. Administered as a nasal spray, Spravato is required to be taken under medical supervision in a healthcare setting. Unlike traditional antidepressants that primarily act on serotonin and dopamine levels, Spravato functions by enhancing glutamate activity, the most prevalent neurotransmitter in the brain, facilitating neuronal communication.
Sales for Spravato have surged, with a remarkable increase of 60%, reaching $271 million in the quarter ending June 30 compared to the same period last year. The drug has been utilized by 100,000 patients across 77 countries.
This advancement in treatment options for those suffering from depression highlights a hopeful trend toward addressing mental health challenges in more effective ways. If approved, Spravato as a standalone therapy could bring significant relief to many individuals who have not found success with conventional treatments, marking a positive step forward in the mental health landscape.