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Panel slams OxyContin trials and says abuse, mortality risks persist.(NEWS FROM THE FDA)
- Article from:
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Family Practice News
- Article date:
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June 1, 2008
- Author:
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Copyright informationCOPYRIGHT 2008 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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In reviewing the tamper-resistant version of OxyContin, a Food and Drug Administration joint panel criticized the trials that were used to demonstrate the new formulation's abuse-proof qualities.
Maker Purdue Pharma LP said it reformulated its currently marketed OxyContin (oxycodone hydrochloride controlled release) to provide "'resistance to certain methods used to defeat the controlled-release mechanism."
But members of the Anesthetic and Life Support Drugs and the Drug Safety and Risk Management advisory committees blasted Purdue's in vitro trials, saying the poor scientific rigor of the trials was almost insulting.
OxyContin can be crushed easily between two ...