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Purdue Pharma L.P. To Present Analysis Of Butrans (buprenorphine) Transdermal System CIII Clinical Data At American Pain Society Annual Meeting

STAMFORD, Conn., May 18, 2012 /PRNewswire/ -- 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.

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]).

The Full Prescribing Information for Butrans contains the following Boxed Warning:

WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS OF USE

Proper Patient Selection

Butrans is a transdermal formulation of buprenorphine 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.

Potential for Abuse

Butrans contains buprenorphine which is a mu opioid partial agonist and a Schedule III controlled substance. Butrans can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the abuse potential when prescribing or dispensing Butrans in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Routinely monitor all patients receiving opioids for signs of misuse, abuse and addiction.

Limitations of Use

Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation.

Avoid exposing the Butrans application site and surrounding area to direct external heat sources. Temperature dependent increases in buprenorphine release from the system may result in overdose and death.

Adverse Event Information

The most common adverse reactions (>5%) included: nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash.

Butrans Transdermal System Dosages

Three strengths of Butrans are commercially available by prescription in retail pharmacies nationwide: 5 mcg/hour (NDC code 59011-750-04); 10 mcg/hour (NDC code 59011-751-04); and 20 mcg/hour (NDC code 59011-752-04). The maximum dose of Butrans is 20 mcg/hour.

The Full Prescribing Information for Butrans, including the Medication Guide and Boxed Warning is available at

About Purdue Pharma L.P.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products.

SOURCE Purdue Pharma L.P.

Posted: May 2012

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