Johnson & Johnson announced on Monday that it has filed a request with the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, so it can be utilized as a standalone treatment for patients with treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was meant to be used in conjunction with an oral antidepressant for individuals whose symptoms did not improve after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the approximately 280 million people worldwide affected by major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, emphasized the challenges faced by patients enduring difficult-to-treat depression. He stated that these individuals often go through numerous ineffective treatments, which can impose considerable functional and emotional strain on both them and their families.
The submitted application included data from a late-stage clinical trial indicating that Spravato, when used as a standalone therapy, can alleviate symptoms in patients as quickly as 24 hours post-treatment, maintaining efficacy for at least four weeks.
Spravato is delivered via nasal spray and requires administration under the supervision of a healthcare professional in a clinical environment. Unlike traditional antidepressants that manipulate neurotransmitters like serotonin and dopamine, Spravato enhances glutamate activity in the brain, which is the primary neurotransmitter facilitating neuronal communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same period in 2023. The drug has been prescribed to around 100,000 individuals across 77 countries, according to the company.