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FDA blocks generic versions of OxyContin over abuse concerns

Wire • Apr 19, 2013 at 2:07 PM

More than 16,000 people died from overdoses of prescription opioid painkillers in 2010, the last year for which the government has figures, which is part of the reason the U.S. Food and Drug Administration on Tuesday halted plans of some generic drug companies to sell their versions of the brand-name painkiller OxyContin.

Applications to sell generic versions were based on the older, non-tamper-resistant version of OxyContin, which some abusers have crushed, liquefied, smoked, inhaled or injected to get high.

The newer, crush-resistant version of OxyContin was approved by the FDA. Generic drugs must follow the official label of the brand-name drug, so the FDA said it would not approve generic versions based on the old formulation.

"The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," Douglas Throckmorton, an FDA deputy director, said in a statement. "While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and to reduce abuse by snorting compared to original OxyContin."

OxyContin is made by Purdue Pharma LP, which is based in Stamford, Conn. Purdue said in a statement that it was "gratified" by the FDA's action, which will also give the company a bit more time before generic competitors can eat away at profits from the sale of the drug. But Purdue also noted that the change won't prevent overdoses by people who simply swallow more tablets than they are supposed to take.

Teva Pharmaceutical Industries Ltd. was among the generic companies planning to compete with an older version. A Teva spokeswoman said the company would comply with the FDA decision.

Meanwhile, Malvern, Pa.-based Endo Health Solutions Inc. is in a similar position as Purdue with its opioid painkiller, Opana ER. The FDA must respond to Endo's request to withdraw approval for its older, non-tamper-resistant version by May 10. An Endo spokesman declined comment.

OxyContin’s reformulation has had a dark side: in a July 2012 letter to The New England Journal of Medicine, a group of researchers revealed that after OxyContin’s reformulation, droves of people addicted to the painkiller but thwarted by the new formulation were turning to a more dangerous drug — heroin — a development likely to result in an uptick of overdoses and deaths.


By David Sell - The Philadelphia Inquirer (MCT)

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