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Results of a Pivotal Phase 3 Efficacy and Safety Study for Butrans® (Buprenorphine) Transdermal System CIII Published in The Journal of Pain
Date:9/23/2011

result in overdose and death.Summary of Clinical StudyPatients evaluated in this randomized, double-blind, double-dummy active controlled, superiority study had moderate-to-severe low back pain for at least three months and were receiving treatment with opioid analgesics at doses between 30 to 80 mg of morphine sulfate or the equivalent at least four days per week for at least 30 days prior to the screening visit.  Sixty-two percent (62%) of patients were taking hydrocodone-containing medications; 21% were taking oxycodone-containing medications; and 12% of patients were taking propoxyphene-containing medications.  Prospective patients were excluded if they were currently using the fentanyl transdermal-system, extended-release hydromorphone, or more than 80 mg per day of oral morphine equivalent for pain control upon entry into the study.

The study employed an enriched design – allowing only patients who both tolerated and responded to Butrans during an open label run-in period to enter into the 12-week double-blind phase of the trial, mimicking the treatment of patients in a clinical practice setting.  

The efficacy and safety of Butrans 20 mcg/hour was assessed using Butrans 5 mcg/hour as the low-dose control group.  All patients wore either active or placebo patches (double-dummy technique).  The study was performed at 75 centers in the United States.

Of the 1160 patients that entered the open-label run-in period, 57% were able to titrate to and tolerate the adverse effects of Butrans 20 mcg/hour and were randomized into a 12-week double-blind treatment phase.  Twelve percent (12%) of patients discontinued due to an adverse event and 21% discontinued due to lack of a therapeutic effect during the open-label titration period. A total of 660 patients were randomized to the double-blind phase to receive Butrans 20 mcg/hour, Butrans 5 mcg/hour, or an active control, for 12 weeks.  During the double-blind t
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SOURCE Purdue Pharma L.P.
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