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FDA Panel Skeptical of New OxyContin Formula
May 6, 2008

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News Summary

Drugmaker Purdue Pharma says that it has made the painkiller OxyContin harder to abuse by adding a plastic-like coating to the pills, but a Food and Drug Administration (FDA) advisory panel said that more testing is needed before the drug can be brought to market, the Associated Press reported May 5.

The FDA typically follows the advice of its advisory panels, although the agency isn't legally bound to do so. "What we heard from the committee was that they have a lot of concern that the formulation had not been adequately evaluated," said Curtis Rosebraugh of the FDA's drug-evaluation office.

The opiate OxyContin has become a popular drug of abuse during the past decade, earning the moniker "hillbilly heroin." Users typically crush the pills to defeat the time-release formula, then snort or inject the powder. The FDA asked its advisory panel to review the latest version of the drug to help determine whether it should be marketed as tamper-resistant, among other concerns.

COMMENTS ON THIS ARTICLE:
(Comments now appear first to last)

Posted by Stephen Buchness on 08 May 08 08:34 AM EDT
Is it just pure coincidence that the article "Painkiller Patches Abused by Addicts" in the same issue of Join Together describes how Canadian addicts get fentanyl out of the newly re-formulated plastic patches? Or are you trying to remind us that all safeguards can be circumvented if the "reward" is strong enough?

Posted by Bob Curley, News Editor, Join Together on 09 May 08 09:56 AM EDT
It was a coincidence that both stories came in the same week, although the relationship between these two did not go unnoticed here.

Posted by Bob on 12 May 08 11:09 AM EDT
Instead of a panel of lab scientists evaluating if a medication can be abused, why not go to the real experts, former drug users, and allow their input and street expertise to become part of the advisory panel testimony?

Posted by John Keppler MD on 12 May 08 03:53 PM EDT
In my experience working with folks with Substance Use disorders a few patients will devote all their efforts into 'beating' almost any system developed(getting a way to access the entire drug at once). I remember Preludins a powerful stimulant similar in effect to methamphetamine. It's whole 75mg dose was encapsuled with a thick coating and inside of that the drug was bound to tiny time release particles. One carefully scraped off the outside capsules of two or three of the tablets, took what remainded into 10 ml of water and using preferably a test tube would boil it down to between 1 and 2ml. You were left with a whitish appearing waxy substance (the binding agent) floating in 2 ml water. The client had placed three sections of coathanger in the freezer 45 min before the boiling process. One then took out a section of the very cold coathanger and stuck it down into the mixture and swirrled it for a few seconds this caused much of the waxy substance to stick to the hanger. At any rate what you were left with was between 1 and 2 ml of concentrated drug and was soluable in H20 For more info see the "Vaults of Erowid" on the internet.

Posted by John on 12 May 08 06:51 PM EDT
I remember when the manufacturer decided that they were going to make Dilaudid safe from injection. These oral tabs were on the market for about a day before it was figured out how to shoot them. Where there is a will there's always a way.

Posted by Peter Lagasse on 14 May 08 10:13 AM EDT
I thought that the concept of placing naloxone into the Oxycontin seemed like an excellent idea to prevent I.V. diversion. The original tabs could still be made for people with allergies to naloxone and the rest could be given the naloxone-treated tabs as a method of harm-reduction. Call them Oxycontin-N or something.

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