A significant milestone has been reached in the fight against treatment-resistant depression. The U.S. Food and Drug Administration (FDA) recently approved Johnson & Johnson’s ketamine-based nasal spray, Spravato, as a standalone therapy for individuals who have not responded to other treatments or are unable to take oral antidepressants.
Previously, Spravato was FDA-approved as an add-on therapy in combination with oral antidepressants for treatment-resistant depression. However, the expanded use marks a new phase, allowing patients to experience potential symptom relief without relying on daily medication.
Ketamine, a chemical relative to esketamine used in Spravato, has been studied for its unique ability to treat depression faster and more effectively than many other medications. Studies since its approval have shown that Spravato can outperform standard alternatives like certain antipsychotics.
A recent double-blind, randomized, controlled trial involving 1279 participants with treatment-resistant depression found that those taking Spravato experienced a significant reduction in symptoms compared to the placebo group. The drug’s potential and safety were confirmed through this post-market phase 4 trial.
Though ketamine carries risks, such as sedation and respiratory depression, the FDA has implemented a REMS program to ensure its use is safe under medical supervision.
This approval marks an exciting step forward for depression treatment, offering hope for those who have struggled with resistant cases. As research continues into compounds like ketamine, there may be new, safer options in the future, potentially revolutionizing mental health care.
Source: https://gizmodo.com/ketamine-nasal-spray-approved-as-standalone-treatment-for-tough-depression-cases-2000553741