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    Reformulated, ’Abuse Resistant’ OxyContin Approved by FDA

    A new slow-release version of the powerful opiate painkiller OxyContin has been approved by the U.S. Food and Drug Administration (FDA).

    The new formulation is designed to prevent the time-released pills from being cut, broken, crushed or dissolved by users looking to get high on the drug. FDA officials described the change to the drug formula as incremental and acknowledged that it will not be foolproof.

    “The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended,” the agency noted.

    The FDA will require OxyContin maker Purdue Pharma to conduct a followup study to determine whether the new formula is effective in reducing misuse of the drug.

    Published

    April 2010