WASHINGTON (AP) – Federal health advisers 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.
Stamford, Conn.-based Purdue Pharma LP has touted the new pill’s plastic-like coating, which is designed to make the drug harder to crush and snort or inject.
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.
Date: September 24, 2009
Source: Associated Press
Filed Under: Drug Discovery