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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

reatment, in the Butrans 20 mcg/hour group, 11% discontinued early due to a lack of therapeutic effect and 13% due to an adverse event; in the Butrans 5 mcg/hour group, 24% discontinued early due to a lack of therapeutic effect and 6% due to an adverse event.

Analysis of the primary efficacy endpoint – "average pain over the last 24 hours" scores – showed that patients treated with Butrans 20 mcg/hour experienced significantly lower pain scores compared to those treated with Butrans 5 mcg/hour. The results of four sensitivity analyses, performed to assess the robustness of the primary efficacy analysis with respect to differing imputation algorithms, were all statistically significant for Butrans 20 mcg/hour compared to Butrans 5 mcg/hour and consistent with the results of the primary efficacy analysis.  There were statistically significant differences in pain scores observed between the active comparator and Butrans 5 mcg/hour treatment groups for all sensitivity analyses.

Treatment-related adverse events were primarily classified as gastrointestinal, general disorders and administration site conditions, and nervous system disorders.  The adverse events most frequently observed during the double-blind phase (greater than or equal to 10%) for patients treated with Butrans 5 mcg/hour and Butrans 20 mcg/hour, were nausea [8%, and 12%]; application site pruritus (itching) [5% and 13% application site]; application site erythema (redness of the skin) [5%, and 10%]; and headache [5% and 11%].

Warnings and Precautions

  • Respiratory Depression: Respiratory depression is the chief hazard with Butrans.  Use with extreme caution in patients at risk of respiratory depression.
  • CNS Depression: Butrans may cause somnolence, dizziness, alterations in judgment and alterations in levels of consciousness, including coma.  Use with caution in patients who are receiving other central nervous sys
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  • SOURCE Purdue Pharma L.P.
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