OxyContin Safeguards May Reduce Abuse

OxyContin, a time-release version of the old narcotic oxycodone, was introduced in 1996 for use by seriously ill patients. It wasn’t long before it acquired the nickname “hillbilly heroin” after abusers found they could get a heroin-like high if they snorted or injected crushed tablets. Recently, the maker of OxyContin, Purdue Pharma LP, designed a new version of the drug with a plastic-like coating that they claim will make it harder to crush, therefore harder to abuse. They now seek FDA approval for the drug. But will the drug work as well on pain? Could there be adverse side effects on patients taking the new pill? And will it really reduce abuse?

On Monday, May 5 the U.S. Food and Drug Administration (FDA) asked an advisory panel to determine if the reformulated version of the drug seems tamper-resistant enough to allow it on the market before long-term studies are done. Dr. Bob Rappaport, the FDA’s chief of painkilling drugs, wrote a letter to the panel which said “there is no perfect formulation that can resist all forms of tampering.” If approved, the label on the new version of OxyContin “would have to be carefully crafted so as to avoid the publication of a road map describing how to defeat these changes.”

The advisory panel, which wasn’t asked by the FDA to formally vote on a recommendation, voiced skepticism that the new version would live up to the drug maker’s claim, saying there is a “striking” lack of data about the drug’s abuse-prevention qualities. Panel member Jeffrey R. Kirsch reportedly said, “I’m fascinated with the poor scientific rigor” of the data presented the company. “It’s almost insulting.” The panel said labeling the painkiller as abuse-resistant might lead doctors to underestimate the continued risk that it could be abused, leading to even more problems. Just last year, Purdue Pharma’s president pleaded guilty to “misbranding” OxyContin by understating its potential for abuse, and the company agreed to pay $600 million to settle a federal investigation.

Ultimately, the panel called for more testing, and while the FDA isn’t bound by the panel’s advice, they usually follow it. In a statement, the company said it would continue to work with the FDA on the new formulation of the drug.

According to the Associated Press, two other companies, Pain Therapeutics, Inc. and King Pharmaceuticals, are also working on an abuse-resistant form of the drug, but in gelatin-like form.