Johnson & Johnson recently announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of its ketamine-based drug, Spravato, allowing it to be prescribed as a standalone therapy for treatment-resistant depression. This proposal aims to enhance treatment options for the approximately 30 percent of the 280 million individuals worldwide suffering from major depressive disorder who do not respond well to conventional therapies.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose symptoms did not improve after trying two or more different antidepressants. Bill Martin, head of neuroscience at Johnson & Johnson, emphasized that many patients enduring difficult-to-treat depression often experience lengthy periods of ineffective treatment cycles, placing significant emotional and functional strains on both them and their families.
The recent application is bolstered by promising results from a late-stage clinical trial, which demonstrated that Spravato, when used alone, began alleviating symptoms in patients as soon as 24 hours following treatment, with effects lasting for at least four weeks. It’s essential to note that Spravato is administered as a nasal spray under the supervision of healthcare providers, differing from traditional antidepressants that primarily affect neurotransmitters like serotonin and dopamine. Instead, Spravato is believed to enhance levels of glutamate, the brain’s most prevalent neurotransmitter, which is crucial for neuronal communication.
The commercial success of Spravato has been notable, with sales increasing by 60% to reach $271 million in the quarter ending June 30, compared to the same time frame in 2023. To date, the medication has been utilized by over 100,000 patients across 77 countries.
This development represents a significant step forward in addressing the needs of those struggling with treatment-resistant depression, offering hope for many who have found little relief from traditional treatment methods. The potential for quicker symptom relief may improve the quality of life for countless individuals facing this challenging condition.