University of Munich, Psychiatric Hospital, Nussbaumstr. 7 Munich Munich, Germany.
Expert Opin Drug Deliv. 2012 Nov;9(11):1409-17. doi: 10.1517/17425247.2012.729574. Epub 2012 Sep 26.
Opioid dependence is a chronic relapsing disorder that shows excess mortality and comorbidity with somatic and psychiatric disorders. Methadone and buprenorphine/naloxone are widely accepted and are used as first-line maintenance treatments for opioid dependence. Fatal intoxications with these agents, risk of diversion, and accidental intoxications, especially in children, are apparent risks and are of increasing public concern. Buprenorphine/naloxone sublingual tablet is an established treatment for opioid dependence. A novel buprenorphine/naloxone film has been developed with improved pharmacokinetics and a hopefully lower risk of diversion and accidental intoxications.
This review evaluates the available preclinical and clinical data on the novel buprenorphine/naloxone film for the treatment of opioid dependence. Literature was identified though a comprehensive PubMed search and data sources included official FDA information.
This is an interesting new formulation of a well-established medication in opioid dependence. However, few data have been published on its safety and efficacy. In an experimental study, the new formulation suppressed symptoms of opioid withdrawal as expected. Results of an unpublished study made public by the FDA suggest a spectrum of adverse events similar to that of the conventional sublingual tablet. Some data show patients may prefer the novel film over the sublingual tablet. The estimated lower risk for diversion and especially for accidental poisoning in children cannot be assessed in clinical studies but requires data from emergency room visits.
阿片类药物依赖是一种慢性复发性疾病，表现为死亡率过高，并伴有躯体和精神障碍。美沙酮和丁丙诺啡/纳洛酮被广泛认可，被用作阿片类药物依赖的一线维持治疗。这些药物的致命中毒、滥用风险和意外中毒，特别是在儿童中，是明显的风险，越来越引起公众关注。丁丙诺啡/纳洛酮舌下片是治疗阿片类药物依赖的一种成熟疗法。一种新的丁丙诺啡/纳洛酮膜剂已经被开发出来，具有改善的药代动力学特性，预计滥用和意外中毒的风险更低。
本文评估了新型丁丙诺啡/纳洛酮膜剂治疗阿片类药物依赖的现有临床前和临床数据。通过全面的 PubMed 搜索确定了文献，数据来源包括官方 FDA 信息。
这是阿片类药物依赖治疗中一种成熟药物的新剂型，非常有趣。然而，关于其安全性和疗效的数据很少。在一项实验研究中，新制剂如预期那样抑制了阿片类药物戒断症状。FDA 公开的一项未发表研究的结果表明，该新制剂的不良反应谱与传统舌下片相似。一些数据表明，患者可能更喜欢新型膜剂而不是舌下片。在临床研究中无法评估其滥用风险和特别是儿童意外中毒风险降低的情况，这需要从急诊室就诊的数据中进行评估。
