Health & Medicine
Generic Version of Crushable OxyContin Blocked by FDA (Video)
Kathleen Lees
First Posted: Apr 17, 2013 11:34 AM EDT
It's a sad day for Rush Limbaugh.
The U.S. Food and Drug Administration just blocked the generic version of crushable OxyContin, a drug that was widely abused throughout the nation by both politicians and celebrities.
"The FDA will not approve any generics to the original formulation of OxyContin," said FDA spokeswoman Morgan Liscinsky according to USA Today, adding that there are no FDA-approved generics of OxyContin on the market now.
The patent on the original drug, set by manufacturer Purdue Pharma, was originally planned to expire Tuesday, causing concerns for health professionals and lawmakers that a generic version would raise the already devastating drug abuse-problem in many states, primarily Kentucky.
According to reports, Kentucky's prescription-pill abuse epidemic is one of the worst in the country, and kills nearly 1,000 residents annually.
"I think (this decision) saves lives," said Karen Kelly, president and chief executive of the Eastern Kentucky anti-drug organization Operation UNITE. "Preventing this from hitting the streets is a major victory."
The FDA decision is also a victory for Purdue Pharma, because generic companies now must develop their own non-crushable formulas before putting an OxyContin version on the market. OxyContin has long been one of the nation's top-selling prescription painkillers, with sales of more than $2.8 billion last year, according to prescription tracker IMS Health.
Addicts could get a high from the drug by crushing, snorting or shooting up its original formula, which was approved by the FDA in 1995. Although it was designed to slowly release the opium derivative oxycodone, abusers learned to tamper with the tablets by cutting, chewing, breaking or dissolving them, releasing high levels of oxycodone all at once.
In 2010, the FDA approved Purdue Pharma's new crush-resistant formulation, which results in a gummy substance that can't be injected if someone tries to dissolve the tablets in liquid. Purdue stopped shipping original OxyContin to pharmacies in August 2010, the FDA said.
Purdue Pharma's abuse-resistant OxyContin goes off-patent in 2025.
Want to find out more about the dangers of the drug? Check out this video, courtesy of YouTube.
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First Posted: Apr 17, 2013 11:34 AM EDT
It's a sad day for Rush Limbaugh.
The U.S. Food and Drug Administration just blocked the generic version of crushable OxyContin, a drug that was widely abused throughout the nation by both politicians and celebrities.
"The FDA will not approve any generics to the original formulation of OxyContin," said FDA spokeswoman Morgan Liscinsky according to USA Today, adding that there are no FDA-approved generics of OxyContin on the market now.
The patent on the original drug, set by manufacturer Purdue Pharma, was originally planned to expire Tuesday, causing concerns for health professionals and lawmakers that a generic version would raise the already devastating drug abuse-problem in many states, primarily Kentucky.
According to reports, Kentucky's prescription-pill abuse epidemic is one of the worst in the country, and kills nearly 1,000 residents annually.
"I think (this decision) saves lives," said Karen Kelly, president and chief executive of the Eastern Kentucky anti-drug organization Operation UNITE. "Preventing this from hitting the streets is a major victory."
The FDA decision is also a victory for Purdue Pharma, because generic companies now must develop their own non-crushable formulas before putting an OxyContin version on the market. OxyContin has long been one of the nation's top-selling prescription painkillers, with sales of more than $2.8 billion last year, according to prescription tracker IMS Health.
Addicts could get a high from the drug by crushing, snorting or shooting up its original formula, which was approved by the FDA in 1995. Although it was designed to slowly release the opium derivative oxycodone, abusers learned to tamper with the tablets by cutting, chewing, breaking or dissolving them, releasing high levels of oxycodone all at once.
In 2010, the FDA approved Purdue Pharma's new crush-resistant formulation, which results in a gummy substance that can't be injected if someone tries to dissolve the tablets in liquid. Purdue stopped shipping original OxyContin to pharmacies in August 2010, the FDA said.
Purdue Pharma's abuse-resistant OxyContin goes off-patent in 2025.
Want to find out more about the dangers of the drug? Check out this video, courtesy of YouTube.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone