FDA Approves Harder-to-Abuse OxyContin Formulation

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Pharmaceutical CommercePharmaceutical Commerce - April 2010

Reformulated drug is a ‘step in the right direction,’ says FDA director

The FDA has approved a new formulation for OxyContin, the powerful controlled-release opioid medication manufactured by Purdue Pharma (Stamford, CT) and popular among recreational drug abusers. Shipping of the reformulated product is expected to begin in the third quarter.

The reformulation makes it harder for the drug to be cut, broken, chewed, crushed or dissolved—processes that allow the oxycodone to be released all at once, instead of incrementally as intended. The FDA says the new formulation “may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection.”

However, the FDA says, the drug could still be misused simply by ingesting larger doses of the medication at a single time.

“Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction,” says Bob Rappaport, FDA’s director of anesthesia and analgesia products.

In its announcement of the FDA approval, Purdue says “there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction.”

The company will be required to conduct a postmarket study analyzing the reformulation’s ability to mitigate drug abuse and misuse. A REMS (Risk Evaluation and Mitigation Strategy) for the drug is also forthcoming.

Be on the lookout for more information on this topic in the April issue of

Pharmaceutical Commerce

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