Reformulation of OxyContin®

The FDA has approved a reformulation of the painkiller OxyContin (oxycodone ER) that has been specially designed to help discourage the misuse and abuse of the medication. When the current formulation is tampered with, it loses its controlled release mechanism, resulting in an immediate release of a high dose of oxycodone. Such immediate high doses of the medication may result in overdose. 

 

The new formulation of OxyContin is intended to prevent the medication from being cut, broken, chewed, crushed or dissolved. However, it still may be abused by ingesting excessive doses. The FDA is requiring Purdue Pharma L.P., the drug manufacturer, to follow a Risk Evaluation and Mitigation Strategy (REMS), including issuing a Medication Guide to all patients using the product and requiring prescriber education on the appropriate use of oxycodone and other opioid analgesics in the treatment of pain. Further details about the REMS have yet to be released by the FDA. Purdue is also being required to conduct post-marketing research to track the significance of the reduction in misuse and abuse of OxyContin following the reformulation’s release. There is no current information regarding its release date.