Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to broaden the approved use of its ketamine-based medication, Spravato. The request aims to allow Spravato to be administered as a standalone therapy for patients suffering from treatment-resistant depression.
Initially approved by the FDA in 2019, Spravato was designed to be used in conjunction with an oral antidepressant for patients whose depressive symptoms did not improve after trying two or more antidepressant medications. Johnson & Johnson highlighted that nearly 30 percent of the approximately 280 million individuals worldwide living with major depressive disorder experience treatment-resistant depression.
Bill Martin, the head of neuroscience at Johnson & Johnson, expressed the challenges faced by patients with hard-to-treat depression, stating that many endure long periods of ineffective treatments, which can lead to significant emotional and functional difficulties for both themselves and their families.
The submission to the FDA is backed by data from a late-stage clinical trial demonstrating that Spravato can alleviate patients’ symptoms as quickly as 24 hours after treatment, and the benefits may last for at least four weeks. Spravato, administered as a nasal spray, is required to be taken under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that target serotonin and dopamine, Spravato functions by enhancing glutamate in the brain, which plays a vital role in neuronal communication.
Sales of Spravato experienced impressive growth, surging 60% to $271 million for the quarter ending June 30, compared to the same timeframe in 2023. To date, the medication has been used by 100,000 individuals across 77 countries.
This potential expansion for Spravato reflects an encouraging advancement in the treatment options available for those struggling with treatment-resistant depression, potentially offering hope to many patients who feel trapped in their battle against this condition. By improving access to effective therapies, Johnson & Johnson may bring significant relief to millions seeking help for their mental health issues.