Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based drug, Spravato, allowing it to be prescribed as a standalone treatment for treatment-resistant depression.
Spravato was first approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients whose symptoms were unresponsive to two or more different antidepressants. Johnson & Johnson indicated that nearly 30 percent of the roughly 280 million individuals worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, remarked in a press release that many patients enduring difficult-to-treat depression often go through numerous ineffective treatments for too long, leading to substantial emotional and functional challenges for them and their families.
The company submitted its application alongside data from a late-stage clinical trial which demonstrated that Spravato, when used as a standalone therapy, could alleviate symptoms in patients as soon as 24 hours after the first treatment and maintain effects for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the guidance of a healthcare professional within a healthcare facility. It operates differently from traditional antidepressants by increasing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates communication between neurons.
Sales for Spravato surged by 60%, reaching $271 million for the quarter ending June 30, compared to the same period in 2023. To date, Spravato has been utilized by 100,000 patients across 77 countries, according to the company.