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.