Oxycontin Abuse may be Limited with New Tamper-Proof Version

The FDA indicates that a new “tamper-proof” version of the painkiller Oxycontin may provide some “limited” benefit in helping prevent abuse of the powerful painkiller, which has been linked to a risk of addiction, overdose and even death.

On Thursday, an FDA advisory panel will review a new version of Oxycontin pills formulated by drug maker Purdue Pharma LP, which includes a coating that makes the drug harder to pulverize into powder and snort. The panel will review data on the new pill and then make a recommendation to the FDA on whether the pills should be approved for use in the United States. Although the FDA is not bound to follow the panel’s recommendations, they usually do.

Oxycontin is a form of the narcotic oxycodone which is designed to release the painkilling medication into the bloodstream gradually over a 12-hour period. Approved by the FDA in 1996, drug abusers quickly discovered that the pill could be crushed and snorted or inhaled for an instant high. Often referred to on the street as “Hillbilly Heroin” or “Killers,” the drug has been linked to hundreds of drug overdoses and deaths.

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The pill is the best-selling prescription pain medication in the U.S., with more than $2 billion in annual sales.

According to Purdue Pharma, the new plastic-like coating would make it very difficult for the drug to be abused by the casual drug user by making it harder to crush and extract the drug from the new coating. Last year the FDA advisory panel rejected a bid for the pill’s approval and told the company that it needed to do more testing on the pills’ resistance to tampering. FDA scientists have acknowledged the new pill would provide “limited” resistance to abuse.

In 2007, Purdue Pharma executives plead guilty to criminal charges that they made false and misleading statements downplaying the risk of Oxycontin addiction to doctors. Sales representatives were told to tell doctors that the drug did not cause euphoric highs and was not as addictive as other pain medications. They also told doctors the drug did not cause withdrawal symptoms.

Company executives agreed to pay $600 million in fines for their actions, and made a number of settlements on individual Oxycontin lawsuits filed against the company on behalf of people who had become addicted to the drug and suffered injuries, financial losses, overdoses or death.

Earlier this month, the consumer advocacy group Public Citizen released a list of “Worst Pills, Best Pills” that listed oxycodone-based medications among the most dangerous pills, in part due to its unpredictable effects when combined with other commonly prescribed medications. The Public Citizen report found that some drugs could unexpectedly boost the potency of oxycodone, increasing the risk of addiction and overdose, while other drugs could suppress the drug’s pain fighting benefits for patients in serious discomfort.


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