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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

inimize opioid withdrawal symptoms in patients randomized to placebo.  Thereafter, the supplemental analgesia was limited to either acetaminophen 500 mg or ibuprofen 200 mg at a maximum of four tablets per day. Of the 257 patients randomized to Butrans, 9% discontinued due to lack of efficacy and 16% due to adverse events.  Of the 284 patients randomized to placebo, 13% discontinued due to lack of efficacy and 7% due to adverse events.  

Results were based on two study arms, Butrans (10 and 20 mcg/hour) and placebo, respectively.  The primary efficacy variable "average pain over the last 24 hours" score at Week 12 was statistically significantly lower for patients randomized to Butrans than for those randomized to placebo.  Sensitivity analyses of the primary efficacy variable and results of analyses of secondary efficacy variables supported the efficacy of Butrans relative to placebo.

In the Butrans group, gastrointestinal disorders, general disorders and administration site conditions, and nervous system disorders were the organ system classifications with the most commonly reported adverse events during the double-blind phase.  Adverse events reported in greater than or equal to 5% of patients during the open-label titration period and double-blind phase were nausea, dizziness, headache, application site pruritus, somnolence, vomiting, and constipation.  

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 system (CNS) depressants.  Additive CNS effects are expected when used with alcohol, benzodiazepines, other opioids, or
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  • SOURCE Purdue Pharma L.P.
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