26-Apr-13 9:00 AM  CST

FDA Approves Abuse-deterrent Labeling for New Formula of OxyContin

The U.S. Food and Drug Administration (FDA) has given the green light approval and updated labeling for Purdue Pharma L.P.’s new formulation of OxyContin (oxycodone hydrochloride controlled-release) pills.  The drug’s brand new labeling will reflect physical and chemical drug properties that will hopefully make drug abuse with this medication harder for individuals who wrongfully use prescription medications through injection and/or snorting. 


Pharmacy technicians may remember the FDA approved the original formation of OxyContin in December 1995 and in April 2010 the FDA approved a reformulated version of the drug.  The reformulated version of the drug was reformed to help ensure less abuse of OxyContin.  Technicians in the pharmacy will be interested to know other facts about the reformulated version.  Some of the features are: 


• Tablets are harder to crush, break, and dissolve for misuse. 

• The newest pills form a viscous hydrogel which makes preparing the drug for injection more of a deterrent to those addicted to drugs. 

•Reformulated and relabeled OxyContin can still be abused orally. 


According to the FDA, they will not accept or approve any abbreviated new drug applications which are generics that depend on the approval of the original version of OxyContin.  Douglas Throckmorton, M.D., and deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research recently commented on the reformulated OxyContin.  “The development of abuse-deterrent opioid analgesics is a public health priority for the FDA.  While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin,” said Throckmorton.


Pharmacy technicians can share this informative, valuable, and news-breaking information with their pharmacist and fellow technicians as it enables them to learn more about their chosen profession. 


1.  Liscinsky, Morgan.  “FDA Approves Abuse-deterrent Labeling for Reformulated OxyContin.”  FDA.  Web.  16 Apr 2013. 


2.  Fiore, Kristina.  “FDA Updates OxyContin Label, Blocks Generics.”  MedPage Today.  Web.  18 Apr 2013. 

For additional information on this article, please contact:
Jennifer S. O'Reilly
Source: NPTAnews  

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