Advisers approve modified pain pill

WASHINGTON – Federal health advisers on Thursday recommended approval for a new version of the painkiller OxyContin that is designed to be harder to abuse.

A Food and Drug Administration panel of experts voted 14-4 in favor of the reformulated OxyContin from Purdue Pharma. However, the same experts recommended the company be required to conduct a follow-up study to track patients taking the drug over the long term.

The FDA is not required to follow the group’s advice, though it usually does.

OxyContin, the nation’s top-selling prescription painkiller last year with sales of more than $2 billion, was hailed as a breakthrough treatment for severe chronic pain when it was introduced in 1996. A time-release version of the narcotic oxycodone, it was designed for use over 12 hours to keep a steady state of the painkiller in the bodies of seriously ill patients.

However, drug abusers quickly discovered they could get a heroin-like high by crushing the pills and snorting or injecting the entire dose at once.

The new pill from Stamford, Conn.-based Purdue Pharma uses a plastic-like coating, which is designed to make the drug harder to crush and snort or inject. However, packaging for the drug will not make any claims about the pill’s tamper resistance.

A federal survey conducted in 2007 found that 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.

The FDA has made a number of public service advisories on the problem with little success, and more recently started pressuring companies to make pain relievers more difficult to abuse.