Effectiveness of 7-day busprenorphine transdermal system in the management of chronic nonmalignant pain syndromes

Abstract

This multicenter (21 UK, 21 US), randomized, double-blind, parallel-group study compared the efficacy and safety of a 7-day buprenorphine transdermal delivery system (BTDS) with placebo transdermal delivery system (PLTDS) in patients with persistent nonmalignant pain requiring combination opioid therapy, using a maintenance of analgesia design. Patients who met stable pain control criteria on BTDS 5, 10, or 20 during an open-label run-in period, were randomized to PLTDS (N = 138) or BTDS (N = 129) at the dose providing stable pain control. End of study was on Day 14 or when patients experienced ineffective treatment. Patients who reached ineffective treatment were PLTDS (65%), BTDS (51%). The odds of ineffective treatment were 1.8 times greater with PLTDS (P = .0217). The median time from first dose of double-blind study drug to ineffective treatment was significantly longer for BTDS compared with PLTDS (10 days vs 3 days). Exploratory analyses did not reveal an influence of potential opioid withdrawal symptoms postrandomization on the time to ineffective treatment. There were no deaths. Nine patients had adverse events that led to discontinuation in the double-blind phase (PLTDS 4; BTDS 5). The incidence of adverse events during the double-blind phase was higher for patients receiving BTDS (48%), compared with PLTDS (40%). Common adverse events reported were erythema at application site (PLTDS 13%; BTDS 13%), and pruritus at site (PLTDS 5%; BTDS 9%). This study supports the efficacy, safety, and tolerability of 7-day BTDS in patients with persistent nonmalignant pain who require opioid therapy. Purdue Pharma, L.P. provided financial support.