FDA approves new labeling for OxyContin

Agency will not approve generic versions without anti-abuse features

SILVER SPRING, Md. — The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said Tuesday.

The FDA announced that it approved updated labeling for reformulated OxyContin (oxycodone) extended-release tablets indicating that it has physical and chemical properties designed to deter drug abusers from crushing or dissolving the pills in order to inject or snort them.

Also, because the original version of OxyContin did not include abuse-deterrent features, the FDA said it would not approve generic versions of that version, which has been withdrawn from the market. The FDA approved the original version of OxyContin in 1995 and the abuse-deterrent version in April 2010; Purdue stopped shipping the original version in August 2010.

The approval of the new labeling comes on the same day as the expiration of OxyContin's patent protection and amid fears that future generic versions of the drug will lack the anti-abuse features of the branded version. OxyContin has long been a drug of choice for drug abusers and a major target for theft. According to the Substance Abuse and Mental Health Administration, about 500,000 people aged 12 and older became new abusers of the drug in 2008.

"The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," FDA Center for Drug Evaluation and Research deputy director for regulatory programs Douglas Throckmorton said. "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."

The Generic Pharmaceutical Association, a trade group that represents generic drug manufacturers, heralded the FDA's announcement.

“We share the Agency’s goal of addressing prescription opioid abuse, and using a science-based approach to take on this complex problem," GPhA president and CEO Ralph Neas said. "At the same time, we recognize the importance of balancing patient access to medicine with efforts to minimize abuse. Yesterday’s decision from the FDA provides clear guidance on what is considered an abuse-deterrent formulation for OxyContin, information that GPhA and its member companies have been seeking since 2010." 

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