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ParagonRx Files with FDA REMS Panel Interim Analysis for Opioid Drugs Study
Date:7/15/2009

WILMINGTON, Del., July 15 /PRNewswire/ -- ParagonRx, a healthcare consulting leader in risk management and the appropriate use of drugs, has filed its interim analysis of a study that shows how its proprietary approach to risk management can help manufacturers of opioid drugs meet FDA standards for risk evaluation and mitigation strategy (REMS.) ParagonRx had presented abbreviated study results to the FDA during public hearings earlier this year.

The interim analysis can be accessed at ParagonRx's website, www.paragonrx.com/experience/comments-to-the-fda/

"ParagonRx has developed a proprietary approach to risk management using an adaptation of failure modes and effect analysis called RxFMEA(R)," says Jeffrey Fetterman, President and CEO of ParagonRx, "and we are currently applying this approach to the medication use process for long-acting opioids. RxFMEA(R) provides a rigorous assessment to identify key causes of sub-optimal outcomes and to prioritize those behaviors that are the most important to address."

ParagonRx is a Delaware-based company that works with pharmaceutical, biotech and medical devices companies to design and implement REMS and other risk management plans as well as better market under-utilized drugs.


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