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Purdue Pharma L.P. Comments on FDA Announcement on REMS for Extended-Release and Long-Acting Opioid Analgesics
Date:7/9/2012

STAMFORD, Conn., July 9, 2012 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) is requiring opioid analgesic companies to implement a new, shared Risk Evaluation & Mitigation Strategy (REMS) for all extended-release and long-acting opioid pain medications to ensure that the benefits continue to outweigh the risks of adverse outcomes (addiction, unintentional overdose, and death) resulting from inappropriate prescribing, abuse, and misuse.  The principal components of this REMS are:

  • prescriber training on all ER/LA opioid analgesics,
  • a Patient Counseling Document on Extended-Release and Long-Acting Opioid Analgesics (PCD), and
  • a Medication Guide for each ER/LA opioid analgesic drug product.

These components are intended to help healthcare professionals better understand the risks and benefits of selecting and prescribing these important medicines, and to educate patients about how to use as prescribed, their risks, and proper storage and disposal.

Purdue supports the goals of enhanced prescriber and patient education as part of a comprehensive approach necessary to address the misuse, abuse, and diversion of prescription medicines, while ensuring these medications remain accessible for people with chronic, moderate to severe pain, when appropriate.

Purdue first developed and implemented risk management programs for its opioid products in 1998, to provide prescribers with information on proper patient selection and assessment, when considering the use of opioid analgesics.  The company has continually provided resources and tools to healthcare professionals to help them recognize and minimize diversion, abuse and addiction.  The company launched FDA-approved product-specific REMS for OxyContin® (oxycodone HCl controlled release) Tablets CII and Butrans® (buprenorphine) Transdermal System CIII in 2010.  The new shared REMS that i
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SOURCE Purdue Pharma L.P.
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