The FDA approved updated labeling for Purdue Pharma’s reformulated OxyContin (oxycodone HCl) 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). The reformulated tablet is more difficult to crush, break, or dissolve which may reduce therapeutic misuse, such as crushing the drug to sprinkle it onto food or to administer via gastric tube.
The original formulation of OxyContin was approved in 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. By August 2010, Purdue Pharma stopped shipping the original OxyContin to pharmacies. The reformulated Oxycontin provides the same therapeutic benefits as the original.
The FDA also announced it will not accept or approve any Abbreviated New Drug Applications (ANDAs) that rely upon the approval of original OxyContin. When FDA finds that a new formulation has abuse deterrent properties, the agency has the authority to require generics to have abuse-deterrent properties also.
Post-marketing assessments of the impact of reformulated OxyContin are ongoing.
For more information call (888) INFO-FDA or visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348252.htm.