Late Tuesday, the U.S. Food and Drug Administration outlawed crushable, generic versions of the narcotic painkiller OxyContin (oxycodone hydrochloride), a drug that has been widely publicized as the posterboy for prescription drug abuse for more than a decade. Meanwhile, the regulators also approved new labeling for a reformulated OxyContin produced by privately held Purdue Pharma L.P. and introduced to the market in 2010. The new version, which is much more difficult to crush or dissolve, is far less prone to tampering.
The drug became known on the streets as OC, O and hillbilly heroin. Some famous people that were either alleged to be addicted or outright said that they needed help getting off the drug included Rush Limbaugh, Courtney Love, Health Ledger and Michael Jackson.
The original formulation of the drug, which abusers were known to crush and inject or snort for a fast high, was approved in 1995. By crushing, the full volume of the narcotic was unleashed at once, rather then over a period of time as intended. The new version turns jelly-like upon crushing. With its reformulation in 2010, Purdue stopped shipping the original product.
“The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route,” the FDA said in a statement Tuesday.
The agency determined that the benefits associated with the original formulation of OxyContin no longer outweigh the risk. Based on that determination, the FDA will no longer accept any generics that rely upon the approval of the original OxyContin.
“The FDA undoubtedly saved our nation from another deadly tidal wave of oxycodone abuse and overdoses," said Kentucky Republican Representative Hal Rogers, Co-Chairman of the Congressional Caucus on Prescription Drug Abuse, in a statement on his website applauding the announcement.
The timing of the FDA decision was precisely planned, coming on the day that the original patent for OxyContin was set to expire, which would have opened the doors to generics to flood the market. The agency said it reviewed several pieces of documentation, some provided by Purdue, in making its decision.
Purdue is the first company ever to use terminology about a drug having tamper-resistant properties to help combat abuse. The decision by the FDA to allow the verbiage could pave the way for Endo Pharmaceuticals Holdings Inc. (ENDP) to fend-off competition through a similar strategy. Endo is seeking approval from the FDA for a new formulation of its powerful painkiller Opana and a ban on its original formulation.
Is it a sketchy move to keep control of the market or is the public’s health at the forefront of the drug makers’ concerns? Realistically, probably a little of both.
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