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OxyContin Gets Label Update

Reformulated tablets have abuse-deterrent properties (Apr. 16)

The FDA has approved updated labeling for reformulated OxyContin (oxycodone hydrochloride; Purdue Pharma) controlled-release tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).

In addition, because original OxyContin provides the same therapeutic benefits as reformulated OxyContin but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely on the approval of original OxyContin.

The FDA approved the original formulation of OxyContin in December 1995. The product was abused, often following manipulation intended to defeat its extended-release properties. Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death. In April 2010, the FDA approved a reformulated version of OxyContin, which was designed to be more difficult to manipulate for purposes of misuse or abuse. Pharmacy shipments of original OxyContin were stopped in August 2010.

The FDA has determined that the reformulated product has abuse-deterrent properties. The tablet is more difficult to crush, break, or dissolve. It also forms a viscous hydrogel and cannot be easily prepared for injection. The agency has determined that the physical and chemical properties of the reformulated product are expected to make the product difficult to inject and to reduce abuse via snorting. However, abuse of OxyContin by these routes, as well as the oral route, is still possible. The reformulated product also may reduce incidents of therapeutic misuse, such as crushing the product to sprinkle it onto food or to administer it through a gastric tube, the agency says.

Source: FDA; April 16, 2013.

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