Evaluation of the Effects of a Monthly Buprenorphine Depot Subcutaneous Injection on QT Interval During Treatment for Opioid Use Disorder

Figures

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  Figure 1. Challenges in identifying baseline heart rate (HR) and QT interval and evaluating any effects of buprenorphine on HR and QT interval. COWS, Clinical Opioid Withdrawal Scale; OUD, opioid use disorder; QTc, heart rate‐corrected QT interval; RR, RR interval.

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  Figure 2. Time‐matched concentration‐QTc for the phase III program and the whole clinical program. Circles represent individual observations; black solid line represents the results from linear regression. The equation with the r 2 is also presented. QTcF, QT after Fredericia correction.

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  Figure 3. Predicted mean delta heart rate‐corrected QT (QTc) at various buprenorphine concentrations with the 90% confidence interval (shaded), including steady‐state 100‐mg (orange) and 300‐mg (red) concentrations and supratherapeutic concentrations (blue). Solid line represents the predicted delta QTc at various buprenorphine concentrations with the shaded area representing the 90% confidence interval; the orange line represents the geometric mean peak concentration (Cmax) at 100 mg every 28 days; the red line represents the geometric mean Cmax at 300 mg every 28 days, and the blue line represents the geometric mean Cmax at 2 × 300 mg every 28 days.