FDA Panel Nixes 'Abuse-Proof' OxyContin
Experts Say Special Coating May Not Stop Abuse of Pain Relief Drug
Data Criticized continued...
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.