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FDA Won’t Approve Generic Oxycontin

Decision signals agency’s intention to insist on abuse-resistant forms of drug.

MICHAEL FITZHUGH

The Burrill Report

“[The FDA has] basically laid down a gauntlet, as it were, saying that they just aren't going to approve generics unless they have exactly the same or better abuse resistant features than Purdue’s reformulated OxyContin.”


The U.S. Food and Drug Administration says it will not approve generics of the powerful pain reliever OxyContin, a move that will offer protection in the short-term for OxyContin-maker Purdue Pharma.

“Because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness,” the agency said in a statement.

Purdue introduced a new formulation of OxyContin in 2010, designed to be more difficult to manipulate for purposes of misuse or abuse. The FDA has now approved new labeling for that reformulation indicating that it has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via snorting.

“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” says Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “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 is expected to reduce abuse by snorting compared to original OxyContin.”

The policy decision by the FDA foreshadows a move away from products without abuse-resistant properties in the market, says Travis Mickle, president and CEO of KemPharm, an Iowa-based company developing a pain reliever designed to reduce abuse potential and opioid-induced constipation.

"[The FDA has] basically laid down a gauntlet, as it were, saying that they just aren't going to approve generics unless they have exactly the same or better abuse resistant features than Purdue’s reformulated OxyContin,” he says. “Whether that happens by legislation or by products moving away from more abusable forms, I think that's going to be the direction.”

The agency issued draft guidance in January to assist companies in developing new formulations of opioid drugs with abuse-deterrent properties. The guidance explained the FDA’s thinking about the studies that drug developers should conduct to demonstrate that a given formulation has abuse-deterrent properties. It also described how those studies will be evaluated by the agency and what labeling claims may be approved based on the results of those studies.

Before the FDA issued that guidance, its stance on how companies develop drugs to address the problem of opioid abuse was vague at best, Mickle. Now the descriptions are very detailed about abuse liability, giving companies such as KemPharm a chance to highlight benefits that will differentiate their products from competitors.


April 19, 2013
http://www.burrillreport.com/article-fda_won%e2%80%99t_approve_generic_oxycontin.html

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