FDA Approves New Abuse-Resistant Formulation of OxyContin

Karen Lee Richards Health Guide
  • Monday the FDA approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication

    As most of you know, OxyContin is the controlled- or extended-release version of the opioid medication oxycodone.  It is prescribed for patients who need round-the-clock treatment for moderate to severe chronic pain.  Controlled-release medications work by slowly releasing the medication over a long period of time (usually 12 hours), which provides more steady pain relief than immediate-release medications that have to be taken every four to six hours. 

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    Extended-release opioids like OxyContin have been popular with drug abusers because they can crush or disolve them, which basically by-passes the slow-release function of the medication and releases all of the drug at once.  This reformulated version of OxyContin is intended to prevent immediate access to the full dose of oxycodone via cutting, chewing, or breaking the tablet. Attempts to dissolve the tablets in liquid result in a gummy substance that cannot be drawn up into a syringe or injected.

    It is hoped that this new forumulation of OxyContin will reduce the likelihood that the drug will be misused and abused, although the FDA stresses that it cannot completely eliminate this possibility.  Purdue Pharma LP, the manufacturer of OxyContin, will be conducting a post-marketing study to determine the impact of the new formulation on the use and misuse of OxyContin.

    The FDA is also requiring a REMS (Risk Evaluation and Mitigation Strategy) that will include the issuance of a Medication Guide to patients and a requirement for prescriber education regarding the appropriate use of opioid analgesics in the treatment of pain.

    My thoughts...

    While the approval of this new formulation of OxyContin doesn't offer any new treatment options for chronic pain patients, I'm always glad to see any new pain medication that has a reduced risk of abuse.  The less the chance a drug can be abused, the more comfortable doctors will be in prescribing it – which is certainly a good thing for pain patients.  I just hope this reformulation does the trick and really reduces the abuse of OxyContin.

Published On: April 06, 2010