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Purdue Pharma L.P. to Present Data From Clinical Program for Butrans™ (buprenorphine) Transdermal System CIII at PAINWeek® 2010
Date:9/9/2010

how efficacy and one study in osteoarthritis, that included an active comparator, failed to show efficacy for Butrans and the active comparator.

Evidence of efficacy has been provided through the study of more than 1,200 patients in two pivotal analgesic trials.  One trial enrolled patients who were opioid-naive while the other enrolled patients who were opioid-experienced. Each of these two adequate and well controlled trials enrolled patients suffering from moderate to severe chronic low back pain, included a 12-week double-blind phase and utilized pain scores as the primary efficacy variable.  Butrans improved pain scores in opioid-naive and opioid-experienced patients with moderate to severe chronic pain requiring continuous, around-the-clock treatment for an extended period of time.

Both of the pivotal clinical studies enrolled adult patients with moderate to severe chronic low back pain and included open-label titration periods followed by randomized, double-blind,  12-week study periods.

One study was a placebo-controlled study that enrolled opioid naive patients who were suboptimally responsive to their non-opioid therapy (e.g., NSAIDs, acetaminophen).  In this study, 53 percent of the patients who entered the open-label titration period were able to titrate to a tolerable and effective dose and were randomized into a 12-week, double-blind treatment period.  Twenty three percent of patients discontinued due to an adverse event and 14 percent discontinued due to lack of a therapeutic effect from the open-label titration period. During the double-blind treatment, in the Butrans 10 or 20 mcg/hour group, 9 percent discontinued early due to lack of efficacy and 16 percent due to adverse events; in the placebo group, 13 percent discontinued early due to lack of efficacy and 7 percent due to adverse events.

The second study used a low dose Butrans control group (Butrans 5 mcg/hour) and enrolled patients who had
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SOURCE Purdue Pharma L.P.
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