Navigation Links
Purdue Pharma L.P. To Present Analysis Of Butrans® (buprenorphine) Transdermal System CIII Clinical Data At American Pain Society Annual Meeting
Date:5/18/2012

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.

(Logo: http://photos.prnewswire.com/prnh/20100921/NY67262 )

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]).

The Full Prescribing Information for Butrans contains the following Boxed Warning:WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS OF USEProper Patient SelectionButrans 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 UseDo 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.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 illicit drugs.
  • QTc Prolongation: Avoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications.
  • Head Injury:  Butrans may worsen increased intracranial pressure and obscure its signs, such as level of consciousness or pupillary signs.
  • Hypotensive Effects: Butrans may cause severe hypotension.  Use with caution in patients at increased risk of hypotension and in patients in circulatory shock.
  • Application Site Skin Reactions: In rare cases, severe application site skin reactions with signs of marked inflammation including "burn," "discharge," and "vesicles" have occurred.
  • Anaphylactic/Allergic Reactions: Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post-marketing experience.
  • Use in Pancreatic/Biliary Tract Disease and Other Gastrointestinal Conditions: Use with caution in patients with biliary tract disease, including acute pancreatitis.  Ileus may occur.  Monitor for decreased bowel motility.
  • Adverse Event InformationThe 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 www.purduepharma.com/PI/prescription/ButransPI.pdf and at www.butrans.com.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.  Additional information about Purdue can be found at www.purduepharma.com.


    '/>"/>

    SOURCE Purdue Pharma L.P.
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. NASCSA Receives $200,000 Grant From Purdue Pharma L.P. to Support State Prescription Drug Monitoring Programs
    2. Purdue Pharma L.P. Provides Free Security Mobiles and Educational Safety Videos to Good Neighbor Pharmacy Members
    3. Purdue Pharma L.P. to Present Data From Clinical Program for Butrans™ (buprenorphine) Transdermal System CIII at PAINWeek® 2010
    4. NASCSA Receives $200,000 Grant From Purdue Pharma L.P. to Support State Prescription Drug Monitoring Programs
    5. RxDrugSAFE™ Featured in National Campaign by Purdue Pharma and NCPA
    6. Purdue Pharma L.P. and the National Community Pharmacists Association Join Forces to Help Prevent Pharmacy Burglary
    7. Purdue Pharma L.P. Re-launches Partners Against Pain Website
    8. New Online Resource to Help Combat Abuse of Prescription Medications Launched by Purdue Pharma L.P.
    9. Purdue Pharmaceuticals Donates Medical Supplies to Protect Poor Children From Infection
    10. NASCSA Receives $200,000 Grant from Purdue Pharma L.P. to Support State Prescription Drug Monitoring Programs
    11. NEA Health Information Network and Purdue Pharma L.P. Partner to Help Kids be Safe
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:3/23/2017)... Research and Markets has announced the addition of the ... Technique, Repair Procedure By Technique, By Region, By Country (2016-2021)" ... ... at a CAGR of 13.35% during 2016-2021 The strong ... growth in population with heart disease and rising advances in minimally ...
    (Date:3/23/2017)... INDIANAPOLIS , March 23, 2017  Eli ... the William Sansum Diabetes Center have established a research ... by diabetes through enhanced research, education and care. ... disease bears a disproportionate weight on Latino families in ... David Kerr , M.D., FRCPE, director of Innovation and ...
    (Date:3/23/2017)... -- Summary Global Markets ... Primary Hyperoxaluria - Pipeline Review, H1 2017, provides ... System And Sex Hormones) pipeline landscape. Primary ... kidney and bladder stones. It results from the ... blood in the urine, pain when urinating, fever, ...
    Breaking Medicine Technology:
    (Date:3/23/2017)... ... March 23, 2017 , ... The physicians of KSF ... the greater Houston Area. The new location is located at 2255 E. Mossy Oaks ... Springwoods Village. This newest location will provide patients living in the north Houston area ...
    (Date:3/23/2017)... ... , ... Texas Physical Therapy Specialists (TexPTS) is pleased to announce the ... clinic is the group’s second in New Braunfels and 22nd in Texas. , TexPTS ... location brings things full circle for the group, “It’s crazy to think that we ...
    (Date:3/23/2017)... ... , ... The IoT (Internet of Things) is revolutionizing the way the world ... businesses and individual consumers alike. Laboratories can maximize their profit margin by increasing ... $4 trillion to $11 trillion dollars by the year 2025. McKinsey expects the IoT ...
    (Date:3/23/2017)... ... 23, 2017 , ... 82% of adults are unaware of the dangers that infectious bacteria play ... the minimum two times a day that dentists recommend. The ramifications of improper oral upkeep ... school and adults missing 164 million hours of work each year due to dental issues. ...
    (Date:3/23/2017)... ... ... March is National Kidney Month – the perfect time to pause and thank ... Every day, two kidneys filter about 120 to 150 quarts of blood. Put another ... regulating fluid levels and blood pressure, supporting bone health and promoting red blood cell ...
    Breaking Medicine News(10 mins):