Tamper-Resistant OxyContin Approved by FDA

The Food and Drug Administration has approved a new form of pain-reliever OxyContin designed to reduce tampering and abuse.

It is difficult to cut, crush, chew, or dissolve the new pills, preserving the slow release of the active ingredient, oxycodone, over time.  If a potential abuser tries to dissolve the pills in water, they form a gummy mass that cannot be injected.

After the new formulation is on the market, the FDA will require Purdue Pharma, the manufacturer of OxyContin, conduct a study of how well it meets the goal of reducing abuse and misuse.  Purdue also must develop a Risk Evaluation and Mitigation Strategy (REMS) that includes a medication guide for patients and education for health care providers on the appropriate use of opiates to manage pain.

OxyContin releases the an opiate pain medicine, oxycodone, slowly over time.  It is helpful to people with chronic pain, including cancer pain, who need round-the-clock pain relief.  Because of its timed release, each pill contains a large dose of oxycodone, making it risky for overdose or abuse.

In the older formulation, caregivers sometimes crushed the pills for patients who had trouble swallowing, resulting in accidental overdoses. OxyContin also has been widely diverted from medical use to drug abuse, where pills were crushed and inhaled or dissolved and injected, releasing a large amount of oxycodone to produce euphoria.

Abuse of OxyContin is high.  According to the 2008 National Survey on Drug Use and Health, half a million new people began misusing it for non-medical purposes.

The FDA warns that the new OxyContin formula does not completely eliminate the risk of overdose or abuse.  People can still take larger than recommended doses.  Health care professionals need to remind patients and their care partners not to exceed prescribed doses of the drug.

Bob Rappaport, MD, director of the Division of Anesthesia and Analgesia Products in the FDA’s Center for Drug Evaluation and Research, commented,

Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction. As with all opioids, safety is an important consideration. 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.