The recent development in medical news is the expanded approval of Spravato (esketamine) nasal spray by the U.S. Food and Drug Administration (FDA). Here are the key points: 1. **Expanded Approval**: Initially approved in 2019 for treatment-resistant depression (TRD) use in conjunction with oral antidepressants, Spravato is now approved as a standalone treatment for major depressive disorder (MDD)[1][2][4]. 2. **Rapid Symptom Relief**: Clinical trials have demonstrated rapid symptom relief within 24 hours, with sustained improvement through 28 days[2][4]. 3. **Addressing Treatment-Resistant Depression**: Spravato targets the glutamate system, offering an alternative for individuals who have not responded well to standard antidepressants that target serotonin, norepinephrine, or dopamine systems[1]. 4. **Safety and Efficacy**: The FDA’s decision is based on extensive clinical trials that have shown the safety and efficacy of Spravato as a standalone treatment, with patients experiencing significant improvements in their depressive symptoms compared to those receiving placebo treatments[1][4]. 5. **Availability and Administration**: Spravato is available through a Risk Evaluation and Mitigation Strategy (REMS) program, requiring administration in a certified healthcare setting under supervision to ensure patient safety[1][3]. This expanded approval represents a significant advancement in the management of depression, providing a new, faster-acting treatment option for millions of people affected by this condition.
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