New OxyContin Formulation to Help Prevent Abuse of the Drug

April 15, 2010 11:07 am

FDA has approved a new formulation of the controlled-release drug OxyContin^® which is designed to decrease the likelihood that this medication will be misused or abused, and result in overdose. FDA explains that the new formulation adds in new tamper-resistant features aimed at preserving the controlled release of the active ingredient, oxycodone. The old formulation allowed tampering with the tablet, via cutting, chewing, breaking, or dissolving, which resulted in dangerously high levels of oxycodone being released at once. In accordance with FDA requirements, Purdue Pharma L.P. will conduct a post-marketing study to determine the impact of the new formulation, and the manufacturers will follow a Risk Evaluation and Mitigation Strategy (REMS) for this product. The REMS will include the issuance of a Medication Guide to all patients who use the product. More information is provided on the FDA OxyContin Question and Answer Web page.