May 07, 2008
Experts say special coating may not stop abuse of pain relief drug.
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. 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.
Sales and abuse up
More than 12% of 18- to 25-year-olds reported using the drug for non medical reasons in 2006, according to federal figures. Those figures also estimate that 500,000 Americans try oxycodone recreationally for the first time each year.
Pharmacy 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.
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. This new product doesn't bring any solution to the vast majority of deaths that occur with this product.
At some points the criticism crossed over into ridicule a member of the panel, said he was "fascinated" with the "poor scientific rigor" or Pharmacy claims that the new OxyContin was truly tamper-resistant.
The panel did not take any formal votes. But it was nearly unanimous that Pharmacy 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. 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.
Three Pharmacy 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.
Source: webmd.com
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