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Last updated on April 17, 2014 at 13:30 EDT

Purdue Pharma L.P. to Present Data on Physician Understanding of the Risk Evaluation and Mitigation Strategy (REMS) for Butrans® (buprenorphine) Transdermal System CIII Data at International Society of Pharmacoeconomics and Outcomes Research Annual Meeting

June 4, 2012

STAMFORD, Conn., June 4, 2012 /PRNewswire/ — Purdue Pharma L.P. will present data evaluating physician understanding of the Risk Evaluation and Mitigation Strategy (or REMS) for Butrans® (buprenorphine) Transdermal System CIII at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 17th Annual International Meeting. The data includes results from a post-test evaluation of prescribers who completed Butrans REMS training between December 2010 and February 2011.

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The poster (#PSY48) will be presented at the ISPOR meeting in Washington, D.C. on Monday, June 4, at 4:30 PM EDT: Butrans® REMS Health Care Provider Training Guide Recall Testing. P. Coplan, A. Kadakia, J. Downing, A. Kline, N. Sessler.

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 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.
    --------------------------------------

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 Information
The most common adverse reactions (greater than or equal to 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.


Source: PR Newswire