Data from Purdue Pharma’s Butrans clinical trials to be presented at APS annual meeting

May 19 2012

Purdue Pharma L.P. will present an analysis of data from completed clinical trials for Butrans® (buprenorphine) Transdermal System CIII at the American Pain Society's (APS) 31st Annual Scientific Meeting.  The analysis includes an evaluation of supplemental analgesic use and pain scores across the 7-day dosing interval.         

The poster will be presented at the APS meeting in Honolulu, HI on Friday, May 18 at 8:45 AM HAST: Butrans® (buprenorphine) Transdermal System and 7-day Analgesic Efficacy. M. Kwarcinski, M. Cataldo, C. Munera, B. Dain Poster #436.

Butrans is indicated for the management of moderate-to-severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time.  Approved by the U.S. Food and Drug Administration (FDA) in June 2010, Butrans is the first transdermal system that delivers continuous release of the active ingredient, buprenorphine, for seven days.

Butrans is a Schedule III opioid prescription medication and can be abused in a manner similar to other opioid agonists, legal or illicit.  Working with the FDA, Purdue Pharma L.P. developed a Risk Evaluation and Mitigation Strategy (REMS) for Butrans that includes a Medication Guide, Elements to Assure Safe Use, such as a healthcare provider training guide, and a timetable for submitting assessments of the REMS.  This information is available at www.Butransrems.com.

Butrans is contraindicated in patients who have: significant respiratory depression, severe bronchial asthma, or known hypersensitivity to any of its components or the active ingredient, buprenorphine. Butrans is contraindicated in patients who have or are suspected of having paralytic ileus. 

Butrans is also contraindicated in the management of: acute pain or in patients who require opioid analgesia for a short period of time, postoperative pain, mild pain, or intermittent pain (e.g., use on an as-needed basis [prn]).