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FDA Panel Nixes 'Abuse-Proof' OxyContin

Experts Say Special Coating May Not Stop Abuse of Pain Relief Drug

Data Criticized continued...

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.


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