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New Formulation of Oxycontin– Will it make a difference?

Posted Sep 25 2009 10:50pm

Oxycontin was not my drug of choice so I don’t know the ins and outs of abusing the medication. But I suppose anything that makes the drug harder to abuse is a good thing. The other things that are being looked at for approval are combinations of agonist with antagonist in small doses– for example Embeda is morphine plus little beads of naltrexone, and orally-active form of naloxone. The naltrexone is only released if the pill is crushed, and there is not enough naltrexone to cause withdrawal, but only enough to reduce the ‘high’. I guess my thought is why limit to a small amount of naltrexone? The drug is not to be injected or snorted, so why not put enough naltrexone in it to make any tampering a very serious downer?

I thought I’d share the article below with you, so you can see how thrilled the FDA is with the new formulation.  Read on…

FDA Panel Recommends Approval of New Oxycodone Formulation
By Emily P. Walker
Published: September 24, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor University of Pennsylvania School of Medicine.

GAITHERSBURG, Md. — An FDA advisory panel voted to recommend approval of a new formulation of oxycodone hydrochloride (OxyContin) that is more difficult to crush or dissolve, and which may deter drug abuse.

By a 14-4 margin, with one abstention, the panel recommended that the FDA approve Purdue Pharma’s application for a new, resin-coated formulation that it hopes will eventually replace the original version, which has been on the market since 1996.

The FDA does not have to follow the advice of its advisory committees, but it usually does.

The advisory panel’s endorsement was less-than-enthusiastic in this case, and members complained that there’s no proof the new version of the drug is any safer than regular oxycodone hydrochloride — one of the few drugs on the market that can be deadly in a single dose.

Purdue’s current pill is meant to be swallowed whole, but abusers can easily chew it or crush it and then snort it, smoke it, or dissolve it in liquid and inject it to achieve a heroin-like high.

Although there is no proof that the new formulation is safer, the panel agreed that making the pills harder to crush, chew, or dissolve into liquid may deter abusers. When the new version of the drug is dissolved into water, it produces a gel, which makes snorting the drug more difficult.

“Clearly the old [formulation] is worse than the new, although I think the difference is relatively small,” said panelist Randall Flick, MD, an anesthesiologist at the Mayo Clinic who voted to recommend approval of the drug.

“My feeling is that there would at least be some incremental improvement in the safety profile,” said panelist Stephanie Crawford, PhD, a pharmacist at the University of Illinois in Chicago.

Some 1.2 million people age 12 and older used OxyContin in 2006 for nonmedical purposes, according to the Department of Health and Human Service’s National Survey on Drug Use and Health.

Purdue originally sought FDA approval for low-dose versions of the new product in 2008, but the agency told the company to develop more clinical data and to apply the technology to all dosages of the drug.

Also, it took until 2008 for the company to convince the advisory panel in 2008 that the drug was any more difficult to tamper with than the original formulation, said panelist Ruth Day, PhD, director of the Medical Cognition Laboratory at Duke University.

This time around, the company convinced the panel that new tablet is harder to dissolve or crush and that the resin excipient might make it harder to take the drug in an unprescribed manner, said Day, who was also a member of last year’s panel.

In one lab test, Purdue researchers used 16 household tools to attempt to crush the tablet into small particles. All 16 tools handily crushed the original OxyContin tablets to a fine powder. Although four of the tools managed to break down the new tablet into shavings or particles, none could turn it into powder.

Even so, FDA staff reviewers concluded that the technology does not make a huge difference in OxyContin’s abuse potential.

Hardcore abusers are likely to devise new ways to break down the harder tablet or figure out which solvents will dissolve it fastest, within “day or weeks of the product’s release on the market,” Flick predicted.

The panelists who voted for approval said they were concerned that Purdue had not developed an adequate Risk Evaluation and Mitigation Strategy for the drug.

The new formulation will keep the name “OxyContin” and be used in seven available doses. Purdue said it will not market the reformulation as a “safer” version.

If it’s approved, Purdue will produce only the newer version and stop shipping the old one.

“Within six to eight weeks [of production] roughly 90% of drug in the supply chain will be the new product,” said Craig Landau, MD, Purdue’s chief medical officer.

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