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.

Authors: Gunderson EW, Hjelmström P, Sumner M, 006 Study Investigators
Abstract
PURPOSE: Sublingual buprenorphine and combination buprenorphine/naloxone (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 t…