Presented at the 2013 AAPM Annual Meeting « Back

Evaluating the Weight-Based Efficacy of 7-Day Buprenorphine Transdermal System

Marc J. Cataldo, PharmD, marc.cataldo@pharma.com¹, Monica Kwarcinski, PharmD¹, Catherine Munera¹, Bradley Dain¹, (1) Purdue Pharma L.P., Stamford, Connecticut

Introduction: The effect of body weight on the absorption of transdermal medications leading to potential alterations in efficacy has often been questioned by healthcare professionals. The purpose of this evaluation is to determine if the efficacy of Butrans® (buprenorphine) Transdermal System is altered by Body Mass Index (BMI). Materials and Methods: A review of BMI was performed for 2,654 patients enrolled in nine randomized, double-bind, clinical studies performed in the U.S. involving seven-day transdermal buprenorphine. In one randomized, double-blind, placebo-controlled, 12-week clinical study that included patients taking transdermal buprenorphine 10 mcg/hour and 20 mcg/hour, a subgroup analysis of BMI was performed. This analysis included mean pain scores at screening and at Week 12 (mean of the average pain over the last 24 hours at Week 12). Subgroup analyses similar to that stated above are planned for the eight other Butrans clinical studies. Results: The mean body mass index (BMI) of 2654 patients was 31.1 kg/m2 (<25 kg/m2, normal to underweight; 25 to <30 kg/m2, overweight; and ≥30 kg/m2, obese). In the one study evaluated, the mean pain score over the last 24 hours at Week 12 was similar across the BMI subgroups (<25 kg/m2; 25 to <30 kg/m2; and ≥30 kg/m2). Conclusions: Preliminary analyses find that transdermal buprenorphine pain scores are similar across the three BMI categories evaluated.

Funding: All authors are employed by Purdue Pharma L.P.