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Effects of a Higher-bioavailability Buprenorphine/Naloxone Sublingual Tablet Versus Buprenorphine/Naloxone Film for the Treatment of Opioid Dependence During Induction and Stabilization: A Multicenter, Randomized Trial

机译:具有更高生物利用度的丁丙诺啡/纳洛酮舌下片对丁丙诺啡/纳洛酮膜对诱导和稳定过程中阿片类药物依赖性治疗的影响:多中心,随机试验

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摘要

Purpose: Sublingual buprenorphine and combination buprenorphinealoxone (BNX) are effective options for the treatment of opioid dependence. A BNX sublingual tablet approved by the US Food and Drug Administration for the induction and maintenance treatment of opioid-dependence in adults was developed as a higher-bioavailability formulation, allowing for a 30% lesser dose of buprenorphine with bioequivalent systemic exposure compared with another BNX sublingual tablet formulation. No data were previously available comparing the higher-bioavailability BNX sublingual tablet to generic buprenorphine or BNX sublingual film; we therefore evaluated treatment retention during induction and stabilization with the higher-bioavailability BNX sublingual tablet versus generic buprenorphine or BNX sublingual film.
机译:目的:舌下丁丙诺啡和丁丙诺啡/纳洛酮联合治疗是阿片类药物依赖的有效选择。美国食品药品监督管理局(FDA)批准了一种BNX舌下片剂,用于诱导和维持成人阿片类药物依赖性,是一种具有更高生物利用度的制剂,与另一种BNX相比,丁丙诺啡的生物等效当量暴露量要少30%舌下片剂配方。以前没有数据可比较生物利用度更高的BNX舌下片剂与通用丁丙诺啡或BNX舌下薄膜的比较。因此,我们评估了具有较高生物利用度的BNX舌下片剂与常规丁丙诺啡或BNX舌下薄膜相比在诱导和稳定期间的治疗保留率。

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