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Butrans® (Buprenorphine) Transdermal System CIII Pivotal Phase 3 Data Published in the Journal of Pain and Symptom Management
Date:10/26/2011

s multi-center, randomized, double-blind, placebo-controlled, parallel-group study employed an enriched design which included a run-in phase of up to 27 days in which 1,024 opioid-naive patients with moderate-to-severe chronic low back pain who were suboptimally responsive to their non-opioid therapy received open-label treatment with Butrans.  

Opioid-naive patients were defined as patients who were receiving less than 5 mg of oxycodone or the equivalent in the 14 days prior to screening, and who did not have a history of daily opioid use of greater than or equal to 5 mg of oxycodone or the equivalent for three months prior to screening, and who, in the opinion of the investigator, were not opioid dependent at time of entry to the study, had not benefitted from or had not tolerated non-opioid therapy, and were deemed to be appropriate candidates for an around-the-clock opioid analgesic regimen.  

Of the 1,024 patients who entered the open-label, dose-titration period, 53% were able to titrate to a tolerable and effective dose of Butrans and were randomized into a 12-week, double-blind treatment period.  Twenty-three percent (23%) of patients discontinued due to an adverse event from the open-label titration period and 14% discontinued due to lack of a therapeutic effect.  Of the patients who were randomized, the mean (SE) Numerical Rating Scale pain scores were 7.2 (0.08) and 7.2 (0.07) at screening and 2.6 (0.08) and 2.6 (0.07) at pre-randomization (beginning of double-blind phase) for the Butrans and placebo groups, respectively.

A total of 541 patients were randomized to receive Butrans (10 or 20 mcg/hour, N=257) or placebo (N=284) in a double-blinded fashion, based on tolerability and analgesic response at the end of the open-label titration period.  During the first seven days of double-blind treatment patients were allowed up to two tablets per day of immediate-release oxycodone 5 mg as supplemental analgesia to m
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SOURCE Purdue Pharma L.P.
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