FDA backs abuse-deterring OxyContin, thwarts generics


In an eleventh-hour action that derailed the possibility of generic formulations of controlled-release oxycodone (OxyContin) from appearing on the U.S. market anytime soon, the Food and Drug Administration announced April 16 that it withdrew its approval of the original, conventional formulation of OxyContin.

Acting on the very day that the patent on the original formulation of OxyContin, held by Purdue Pharma, was set to expire, the FDA took an additional step to support the newer formulation of OxyContin that Purdue has marketed exclusively since August 2010. The newer version includes a polymer so that, when a pill is crushed and then mixed with water it turns into a gel rather than remaining a more easily manipulated powder. The FDA approved updated labeling for OxyContin that highlights the abuse-deterring features of the newer formulation, which means that Purdue can now cite these attributes when marketing the drug.

The FDA "approved labeling for reformulated OxyContin stating that it possesses physiochemical properties that are expected to: (1) make abuse via injection difficult, and (2) reduce abuse via the intranasal route. This is the first opioid product for which FDA has approved labeling that includes statements regarding abuse-deterrence," according to a letter from FDA Commissioner Margaret A. Hamburg sent April 16 to Rep. Fred Upton (R-Mich.) and Sen. Tom Coburn (R-Okla).

"We applaud FDA Commissioner Hamburg’s announcement that the FDA will not approve any abbreviated new drug applications that rely upon the approval of original OxyContin which did not have abuse-deterrent properties," the lawmakers said in a statement. "With more than 16,000 Americans dying from opioid drug overdoses each year, Commissioner Hamburg’s announcement is a significant step forward in the federal government’s effort to reduce opioid drug abuse and protect consumers. For too long, drug abusers have been able to crush or dissolve opioid drug products in order to defeat their time-release mechanisms for snorting or injecting the drugs."

For patients, the major downside of the FDA’s action is economic. OxyContin retails for about $7.50 per tablet and had roughly $2.7 billion in U.S. sales in 2012. The patent on the abuse-deterring formulation of the drug lasts until 2025.

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