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article imagePurer, stronger painkiller coming; critics predict epic abuse

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By Joan Firstenberg     Dec 27, 2011 in Health
Washington - With opiate painkillers already on the market like OxyContin, hydrocodone and even Vicodin, why would we need another stronger, purer one? But four different pharmaceutical firms are currently madly working to release their versions of it.
People who must live with chronic pain, or suffer a painful injury or have surgery are usually given opiates like hydrocodone or oxycodone and both are usually mixed wIth acetaminophen to ease their suffering. These medicines not only block pain, but also give a patient a sense of well being. The incredible downside is that they are highly addictive and are extensively being used illegally by people age 12 and up to get high.
Time's Healthland reports that while doctors say they welcome alternatives to help their patients, abuse experts are critical of the new class of opiates. April Rovera is president of the National Coalition Against Prescription Drugs Abuse.
"I have a big concern that this could be the next OxyContin. We just don’t need this on the market.”.
FDA statistics reveal that more than 33 million Americans, teens and older misused extended-release and long-acting opiates during 2007; that's up from 29 million just five years earlier.
That abuse is what is leading experts to question the wisdom of a stronger, purer version of hydrocodone, one that is estimated to be ten times stronger than Vicodin (acetaminphen and hydrocodone blend).
Healthland.com reports that four pharmaceutical manufacturers have a hydrocodone derivative near to being released. The one closest to market is Zohydro from Zogenix. Zogenix has already completed three rounds of testing, and has announced it had a final meeting with FDA officials to talk about the upcoming drug application. The plan is to file it in the first quarter of 2012 and have the drug on the market one year later.
Zohydro will come in a time-release version, which is the standard optimum strategy to keep pain at bay. But this companies' pill will be crushable, which destroys the time-release function and delivers a rush to abusers.
Pfizer Inc and Acura Pharmaceuticals Inc have also received approval of a pain drug, But their designs are focused on combatting widespread abuse of opiom-based painkillers. Their pills, to be called Oxecta, will still contain oxycodone, but it will have safeguards should the pill be crushed or mixed with water.
If Oxceta is dissolved in water it becomes a gel, which cannot be drawn into a needle to shoot up. If the tablet is crushed and snorted a new technology will make a person's nasal passages severely irritated and painfully sore. These pills are expected to be available in the first half of 2012.
Critics say they are especially worried about Zohydro, a timed-release drug meant for managing moderate to severe pain, because for abusers who crush it, it releases an intense and immediate high.
The mother of all these derivatives, OxyContin was introduced in 1995 by Purdue Pharma of Stamford, Conn. It was a time-release formula that dribbled one dose of oxycodone over many hours. But abusers quickly found that they could eliminate the timed-release feature by crushing the pills. Purdue Pharma responded by changing the formula, making the drug more tamper-resistant. But addicts moved onto generic oxycodones that don't have the time-released feature.
The Drug Enforcement Administration's yearly count of drug seizures sent to police laboratories for analysis reveals that Oxycodone is now the most-abused drug in the U.S. Hyrdrocodone comes in second.
This is big, very big business for the pharmaceutical companies. It's a $10 billion-a-year legal market for opiate narcotics. Peter Jackson, a co-founder of Advocates for the Reform of Prescription Opiods says,
“It’s like the wild west. The whole supply-side system is set up to perpetuate this massive unloading of opioid narcotics on the American public.”
The pharmaceutical firms say their research is part of a constant search for better painkillers to treat the aging U.S. population. Karsten Lindhardt is chief executive of Denmark-based Egalet, which is in the process of testing its pure hydrocodone drug.
“Sometimes you circulate a patient between various opioids, and some may have a better effect than others.”
The drug companies understand that a pure hydrocodone pill would circumvent liver problems that are linked to high doses of acetaminophen, which is an ingredient in products like Vicodin. They also say that with these new drugs, patients will be more closely supervised because, by law, they will have to go back to their doctors for each refill. But prescriptions for the weaker, hydrocodone-acetaminophen pills which are currently on the market can be refilled up to five times.
Critics say this is a worrisome development because of the dark side that accompanies street use of these narcotic painkillers: These include murders, pharmacy robberies and millions of dollars lost by hospitals that have to treat overdose victims. In addition, they point out that thousands of legitimate pain patients are becoming addicted to these painkillers. Another problem is that after taking them for some time, opiates stop working, and users are forced to take higher doses or resort to different, perhaps more dangerous chemicals. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing says the narcotics problem is out of control.
“You’ve got a person on your product for life, and a doctor’s got a patient who’s never going to miss an appointment, because if they did and they didn’t get their prescription, they would feel very sick. It’s a terrific business model, and that’s what these companies want to get in on.”
The Centers for Disease Control and Prevention reported last month that for the year 2008, prescription painkillers caused the deaths of almost 15,000 people, more than triple the 4,000 deaths in 1999. And the Drug Enforcement Administration says that emergency room visits caused by hydrocodone abuse shot up from 19,221 in 2000 to 86,258 in 2009.
Drug control advocates say they believe the U.S. government is too lax about controlling addictive pain medications. The International Narcotics Control Board did a study in 2008, and found that America consumes 99 percent of the world’s hydrocodone and 83 percent of its oxycodone.
There is a 41-year-old loophole that critics want changed. The federal Controlled Substances Act, which was passed in 1970, put fewer controls on combination pills containing hydrocodone and another painkiller than it does on the equivalent oxycodone products. What this means is that a Vicodin prescription can be refilled five times, while a Percocet prescription can only be filled once.
The Drug Enforcement Administration and the Food and Drug Administration have been studying whether to close this loophole since 1999 but have made no decision. Congress is now discussing a bill that would force the agencies to tighten the controls. Drug critic Peter Jackson says,
“This is a problem that is fundamentally an oversupply problem. The FDA has kind of opened the floodgates, and they refuse to recognize the mistakes made in the past.”
article:316801:12::0
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