New OxyContin Formulation Wins FDA Approval

A newly approved formulation of Purdue Pharma's opioid painkiller makes the drug more resistant to tampering by breaking or crushing, which the FDA says has been linked to fatal overdose and high rates of abuse in recent years.

A newly approved formulation of Purdue Pharma’s opioid painkiller makes the drug more resistant to tampering by breaking or crushing, which the FDA says has been linked to fatal overdose and high rates of abuse in recent years.

The FDA announced Monday its approval of a new formulation of Purdue Pharma’s OxyContin that could reduce intentional misuse of the drug. The reformulated medication is designed to discourage methods commonly used by abusers to coax an immediate release of oxycodone from the controlled-release tablets.

Both formulations of OxyContin tablets contain large quantities of the drug’s active ingredient, which is released over an extended period of time in order to deliver continuous relief from moderate to severe pain. Patients who take the medication as directed are able to take it less often; however, those with intent to abuse have in the past found ways to tamper with the pills, causing them to release a full dose instantaneously if injected, inhaled, or otherwise ingested.

The new tablets are bioequivalent to the current formulation of OxyContin, but are physically resistant to cutting, chewing, crushing, and breaking. When dissolved in liquid, the tablets will yield a gummy, hard-to-inject substance, reducing but not eliminating the potential of abuse and fatal overdose, the FDA said.

Bob Rappaport, MD, director of the Division of Anesthesia and Analgesia Products in the FDA’s Center for Drug Evaluation and Research, called the reformulation a “step in the right direction,” but urged health care providers to continue educating patients on the risks associated with the use of all opioids.

Currently, no evidence is available to validate the new formulation’s efficacy in preventing misuse, diversion, or addiction, Purdue said in a press release. “Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain,” said Rappaport.

The new tablets will look similar to the currently marketed tablets, but are larger in size and marked with a new imprint code, which reads “OP” instead of “OC.” The company will begin distributing reformulated OxyContin to pharmacies in the third quarter of 2010.

In compliance with FDA requirements, Purdue has agreed to conduct follow-up research and implement risk management strategies to monitor the impact of its new formulation on both the directed and nonmedical use of OxyContin.

For more information about the safe use of OxyContin and other pain medicines, visit the FDA’s resource “A Guide to Safe Use of Pain Medicine.”

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