http://www.medscape.com/viewarticle/...=25&uac=3807FR

FDA Panel Nixes 'Abuse-Proof' OxyContin
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Todd Zwillich
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May 11, 2008 — A panel of expert advisors to the FDA took a dim view Monday of efforts by OxyContin's manufacturer to market a new form of the prescription painkiller designed to cut down on tampering and abuse.

The deliberations were a setback for the firm, Purdue Pharma. It was stung a year ago when the company and three of its executives pleaded guilty to illegally hiding the addictive potential of the drug, which is a narcotic.

The company now wants to sell a new form of the drug coated in a plastic-like polymer that prevents potential drug abusers from easily grinding tablets into a fine powder. That makes it hard to snort the drug or "cook" it for intravenous injection.

When it is "cooked," it forms a gelatin ball that is difficult to draw into a syringe. But the coating does not affect how the tablets dissolve in the gut, so patients would still be able to use the drug for pain relief, the company said.

Sales and Abuse Up

Sales of oxycodone, including several generic forms as well as Purdue Pharma's brand name OxyContin, have shot up since its extended-release form was approved in 1996. According to the FDA, sales peaked at 42.2 million prescriptions last year, and with them abuse rates have also gone up.

More than 12% of 18- to 25-year-olds reported using the drug for nonmedical reasons in 2006, according to federal figures. Those figures also estimate that 500,000 Americans try oxycodone recreationally for the first time each year.

Purdue Pharma officials tried to show that the polymer cut down on the amount of active drug that an addict could extract from a tablet.

"We can argue that we have met some degree of tamper resistance. But the abuse resistance is yet to be determined," said J. David Haddox, MD, Purdue Pharma's vice president of risk management and health policy.

Data Criticized

But while experts supported the idea of tablets that are hard to misuse while keeping OxyContin available for pain patients, they said the company failed to show that the new form would cut down on abuse in the real world.

The company did not show, for instance, whether motivated addicts with some facility in chemistry would be able to find ways around the polymer coating, experts said.

Panelist Lewis Nelson, MD, said the product could present doctors and regulators with a "false sense of security" that oxycodone is now safe, despite the fact that most overdoses follow the drug being swallowed orally.

"This new product doesn't bring any solution to the vast majority of deaths that occur with this product," said Nelson, director of the medical toxicology program at New York University School of Medicine.

At some points the criticism crossed over into ridicule. Jeffrey R. Kirsch, MD, a member of the panel, said he was "fascinated" with the "poor scientific rigor" or Purdue Pharma's claims that the new OxyContin was truly tamper-resistant.

"Almost to the point of being insulting," added Kirsch, a professor of anesthesiology from Oregon Health and Science University.

"The data presentation I would not allow in an honors undergraduate thesis to go forward," added Ruth S. Day, PhD, a panelist from Duke University.

The panel did not take any formal votes. But it was nearly unanimous that Purdue Pharma should not be allowed to proceed with a plan to sell lower OxyContin doses in the coated form while still selling higher, 60- and 80-milligram doses in the original form.

Doing so would confuse physicians and drive addicts to seek out the old forms of the drug, experts said.

In a statement, the company said it "will continue to work with the FDA on our New Drug Application (NDA) for a new formulation of OxyContin (oxycodone HCl controlled-release) Tablets."

"Untreated and undertreated pain is a serious public health issue in the United States," the statement said.

Three Purdue Pharma executives and the company agreed to pay a combined $634.5 million in fines after pleading guilty to illegally promoting OxyContin to doctors and withholding data on its abuse potential.

SOURCES: National Survey on Drug Use and Health, 2006, Substance Abuse and Mental Health Services Administration; J. David Haddox, MD, vice president, risk management and health policy, Purdue Pharma; Lewis Nelson, director, medical toxicology program, New York University School of Medicine; member, FDA panel; Jeffrey R. Kirsch, professor of anesthesiology, Oregon Health and Science University; member, FDA panel; Ruth S. Day, PhD, Duke University; member, FDA panel; Statement, Purdue Pharma.




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Todd Zwillich is a freelance writer for WebMD.


WebMD Health News 2008. © 2008 WebMD Inc.

Hi Todd,
Thanks for the interesting article. I just wanted to say to anyone who looked up this thread, to go very steady if you have been prescribed Oxycontin and want to come off it.
I was on Oxycontin, Lyrica and Tramadol for the pain in my arm, neck and back prior to surgery, in April 2008, at C6/7. Post surgery I am still in pain unfortunately, (but that's another story) but decided after the death of Heath Ledger to come off the Oxycontin, as I hadn't realised how potent it could be. I was on 100mg tablet morning and night, and was advised by my GP (I am in Australia, by the way) to cut out 1/2 tablet morning and night. However after a few days getting anxiety, the jitters and diarroeah(sorry spell check won't correct this!) a friend gave me some great advice and suggested 1/4 tablet at a time. So first I cut the morning by 1/4 - then a few days later another 1/4. Then I did the nighttime 1/4 then 1/4; Then back to the morning again and finally the night.
It may just have been me who reacted so badly - but just in case anyone is looking at the Oxycontin reference and wondering about cutting it out - here's one way of doing it. I had been on Oxycontin for around 6 months, and prior to that some Morphine type patches which totally didn't agree with me. Sadly, due to the pain I've actually had my dosage of Lyrica and Tramadol increased - I guess the Oxycontin was being effective, but it worried me a bit. Now I am 2 months post op and having 2 sessions a week of hydrotherapy and physiotherapy to help with post op rehab and pain relief.
Good luck to anyone out there who still has pain. I've been told by a nurse friend that it can take a full year for the fusion and nerve damage to repair - ah well, every day is another day forward anyway.

dont EVER cut,chew, crush, an oxycontin or ms contin or any other control release drug! if you want to cut the dose you need to get the doc to prescribe lesser dose tabs....!!!!!!