Once-Weekly Transdermal Buprenorphine Application Results in Sustained and Consistent Steady-State Plasma Levels Ram P. Kapil, PhD, Alessandra Cipriano,

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Once-Weekly Transdermal Buprenorphine Application Results in Sustained and Consistent Steady-State Plasma Levels Ram P. Kapil, PhD, Alessandra Cipriano, BS, Kristen Friedman, MPH, Gregory Michels, MS, Manjunath S. Shet, PhD, Salvatore V. Colucci, MS, Glen Apseloff, MD, FCP, Joseph Kitzmiller, MD, PhD, CPI, Stephen C. Harris, MD Journal of Pain and Symptom Management Volume 46, Issue 1, Pages 65-75 (July 2013) DOI: 10.1016/j.jpainsymman.2012.06.014 Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions

Fig. 1 Study design. P1, P2, and P3 represent study periods 1 to 3, each consisting of a single seven-day buprenorphine transdermal system (BTDS) 10 patch application. One BTDS 10 was applied on the morning of Days 1, 8, and 15 (Patch 1, 2, and 3, respectively) and worn for 7 days. BTDS 10 applications were restricted to three body sites, and each subject was randomly assigned to one of the 6 possible body site application sequences that included each of these three sites. On Days 8, 15, and 22 the applied BTDS 10 was removed, and on Days 8 and 15 a new BTDS 10 was applied to the next assigned body site. Subjects were discharged from study unit on Day 24. Subjects returned to the study unit on Days 25, 26 and 27 for pharmacokinetic (PK) sampling. In addition, subjects returned for a post-study medical visit (EOS) 7-10 days (Days 29–32) after the removal of BTDS 10 Patch 3 (Day 22) or early discontinuation. Journal of Pain and Symptom Management 2013 46, 65-75DOI: (10.1016/j.jpainsymman.2012.06.014) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions

Fig. 2 Subject disposition. Journal of Pain and Symptom Management 2013 46, 65-75DOI: (10.1016/j.jpainsymman.2012.06.014) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions

Fig. 3 Mean plasma buprenorphine concentrations versus time following three consecutive 7-day applications of buprenorphine transdermal system (BTDS) 10 in 36 healthy subjects. (a) Mean (SD) plasma buprenorphine concentrations for three sequential BTDS 10 applications. (b) Overlay of mean plasma buprenorphine concentrations across each 7-day period. Journal of Pain and Symptom Management 2013 46, 65-75DOI: (10.1016/j.jpainsymman.2012.06.014) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions