2018年9月7日，美国FDA批准Cassipa(丁丙诺啡和纳洛酮)舌下薄膜的新剂量(丁丙诺啡16毫克/纳洛酮4毫克)用于阿片类药物依赖的维持治疗。
  美国FDA致力于帮助那些阿片类药物使用障碍的患者，帮助这些人过渡到清醒的生活状态，并采取了一系列措施来推动阿片类药物依赖治疗方法的发展，并鼓励医疗保健专业人员确保患者能够从这些疗法中受益。
  药物辅助治疗(MAT)是一种综合方法，将FDA批准的药物(目前有美沙酮，丁丙诺啡或纳曲酮)与行为疗法相结合，以治疗阿片类药物使用障碍(OUD)患者。定期坚持使用丁丙诺啡与MAT减少了阿片类药物戒断症状和使用阿片类药物的愿望，而不会引起与阿片类药物滥用或滥用相关的高潮和低谷的循环。在适当的剂量下，丁丙诺啡也会降低其他阿片类药物的愉悦效果，使持续的阿片类药物滥用减少吸引力。根据美国物质滥用和精神卫生服务管理局的研究，接受MAT治疗其OUD的患者将全因死亡风险降低了一半。
FDA approves Cassipa for medication-assisted treatment for opioid dependence
U.S. Food and Drug Administration today approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths.
“There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder. The introduction of new treatment options has the potential to broaden access for patients. For example, the FDA recently described a streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine. This streamlined approach can reduce drug development costs, so products may be offered at a lower price to patients and we can broaden access to treatment,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to helping those with opioid use disorder transition to lives of sobriety. We’ve taken a number of steps to advance the development of new FDA-approved treatments for opioid dependence and encourage health care professionals to ensure patients are offered an adequate chance to benefit from these therapies. We’re also working to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as one approach to the successful treatment of addiction. Despite what some may think, individuals who successfully transition onto medication-assisted treatment are not swapping one addiction for another. Opioid replacement therapy can be an important part of effective treatment. Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication.”
Medication-assisted treatment (MAT) is a comprehensive approach that combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder (OUD). Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for treatment of their OUD cut their risk of death from all causes in half.
Improving access to prevention, treatment and recovery services, including the full range of MAT, is a focus of the FDA’s ongoing work to reduce the scope of the opioid crisis and one part of the U.S. Department of Health and Human Services’ Five-Point Strategy to Comba