阿片类物质使用障碍（MOUD）的药物治疗
正文 · 中文译文
阿片类物质使用障碍（OUD）药物治疗（MOUD） 美国食品药品监督管理局（FDA）过量用药预防框架 过量用药预防活动时间线 阿片类物质使用障碍（OUD）是一种慢性疾病。2025年，美国估计有400万名12岁及以上人群患有OUD。对于中重度OUD患者，已有安全有效的FDA批准药物。阿片类物质使用障碍药物治疗（MOUD）属于三个药理学类别：阿片受体激动剂（美沙酮）、部分激动剂（丁丙诺啡，有经黏膜和缓释制剂）和拮抗剂（纳曲酮，缓释剂型）。FDA批准的药物可在Drugs@FDA查询。FDA正在努力支持新型OUD治疗方法的研发，并帮助更多人了解治疗选择。 应对MOUD治疗障碍 FDA参与旨在提高对OUD治疗认识并解决治疗障碍的工作。名为“自信处方：阿片类物质使用障碍患者需要您”的活动鼓励各类初级保健执业环境中的医疗服务提供者对OUD进行筛查，并与患者协作管理该病，就如同管理哮喘、糖尿病或抑郁症等其他慢性疾病一样。FDA支持获得安全有效治疗的工作包括更新和澄清MOUD标签及其他活动： 里根-尤德尔FDA基金会发布了一份由FDA资助的报告，内容涉及针对儿童非故意暴露于MOUD的非污名化信息传递 FDA提供关于经黏膜丁丙诺啡标签的补充信息 FDA建议对经黏膜丁丙诺啡标签进行更改 FDA与SAMHSA发布函件，明确丁丙诺啡处方要求 FDA批准首个仿制缓释注射用纳曲酮 以阿片类药物使用障碍药物治疗（MOUD）推进循证治疗 FDA正在努力识别和解决额外的治疗需求，并支持开发用于阿片类药物使用障碍（OUD）的新的循证治疗选择。主要活动包括： FDA批准新的4 mg和12 mg丁丙诺啡舌下片 FDA批准缓释注射用丁丙诺啡的标签变更 FDA批准新的缓释注射用丁丙诺啡 FDA与里根-尤德尔FDA基金会合作，就丁丙诺啡治疗OUD召开公开会议 FDA发布指南：证明MOUD有效性的终点指标 FDA资源 应对物质使用和过量预防的精选FDA活动与重大事件时间线 FDA警告丁丙诺啡药品相关的牙科问题并更新用药指南 FDA过量预防框架 外部资源 SAMHSA：TIP 63：阿片类药物使用障碍的药物 SAMHSA：OUD治疗项目目录 CDC：将OUD患者与药物治疗相连接 MedPage Today：医疗服务提供者，你们是缺失的一环：你们的OUD患者需要你们 里根-尤德尔FDA基金会：物质使用障碍 内容截至日期： 11/04/2026 受监管产品 药品
正文 · 英文原文
Medications for Opioid Use Disorder (MOUD) Food and Drug Administration Overdose Prevention Framework Overdose Prevention Activities Timeline Opioid use disorder (OUD) is a chronic medical condition. In 2025, an estimated 4 million people in the U.S. aged 12 or older had an OUD. For people with moderate-to-severe OUD there are safe and effective FDA-approved medications. Medications for opioid use disorder (MOUD) fall under three pharmacological categories: opioid agonist (methadone), partial agonist (buprenorphine, available in transmucosal and extended-release formulations) and antagonist (naltrexone, extended-release). FDA-approved medications can be found at Drugs@FDA. The FDA is working to support the development of new OUD treatments and help more people learn about treatment options. Addressing MOUD Treatment Barriers The FDA is involved in efforts to increase awareness of OUD treatments and address treatment barriers. The campaign, Prescribe with Confidence: Patients with Opioid Use Disorder Need You, encourages providers across a variety of primary care practice settings to screen for OUD and manage it collaboratively with patients, just as they would for other chronic conditions, such as asthma, diabetes, or depression. The FDA’s work to support access to safe and effective treatment includes updated and clarified MOUD labeling and other activities: The Reagan-Udall Foundation for the FDA publishes an FDA-funded report on non-stigmatizing messaging addressing pediatric unintentional exposure to MOUD FDA provides additional information on transmucosal buprenorphine labeling FDA recommends changes to transmucosal buprenorphine labeling FDA and SAMHSA issue letter clarifying requirements for prescribing buprenorphine FDA approves first generic extended-release injectable naltrexone Advancing Evidence-Based Treatment with MOUD The FDA is working to identify and address additional treatment needs and support the development of new, evidence-based treatment options for OUD. Key activities include: FDA approves new 4 mg and 12 mg buprenorphine sublingual tablets FDA approves labeling changes for extended-release injectable buprenorphine FDA approves new extended-release injectable buprenorphine FDA, in collaboration with the Reagan-Udall Foundation for the FDA, convenes a public meeting on buprenorphine treatment for OUD FDA issues guidance: Endpoints for Demonstrating Effectiveness of MOUD FDA Resources Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention FDA Warns about Dental Problems with Buprenorphine Medicines and Updates Medication Guide FDA Overdose Prevention Framework External Resources SAMHSA: TIP 63: Medications for Opioid Use Disorder SAMHSA: OUD Treatment Program Directory CDC: Linking People with OUD to Medication Treatment MedPage Today: Providers, You Are the Missing Piece: Your Patients With OUD Need You Reagan-Udall Foundation for the FDA: Substance Use Disorders Content current as of: 11/04/2026 Regulated Product(s) Drugs