Painkiller 10 times stronger than Vicodin worries addiction experts

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(CBS/AP) As pharmaceutical companies are approaching the final stages of development for a new type of painkiller said to be 10 times stronger than Vicodin, addiction experts worry a new wave of abuse may soon follow.

PICTURES: Painkiller deaths: 15 states with highest rates

Four companies have begun patient testing on the pills which contain a pure version of the highly addictive painkiller hydrocodone, and one of them - Zogenix of San Diego - plans to apply early next year to begin marketing its product, Zohydro.

If approved, it would mark the first time patients could legally buy pure hydrocodone. Existing products combine the drug with nonaddictive painkillers such as acetaminophen.

Hydrocodone belongs to family of drugs known as opiates or opioids because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine, and methadone.

Critics are especially worried about Zohydro, a timed-release drug meant for managing moderate to severe pain, because abusers could crush it for an intense, immediate high.

"I have a big concern that this could be the next OxyContin," said April Rovero, president of the National Coalition Against Prescription Drug Abuse. "We just don't need this on the market."

OxyContin, introduced in 1995 by Purdue Pharma of Stamford, Conn., was designed to manage pain with a formula that dribbled one dose of oxycodone over many hours. Abusers quickly discovered they could defeat the timed-release feature by crushing the pills. Purdue Pharma changed the formula to make the pill more tamper-resistant, but addicts have moved onto generic oxycodone and other drugs that are not time-released.

Oxycodone is now the most-abused medicine in the U.S., with hydrocodone second, according to the Drug Enforcement Administration.

The latest drug studies come as more pharmaceutical companies are getting into the $10 billion-a-year legal market for powerful yet highly addictive opioid narcotics.

"It's like the wild west," said Peter Jackson, co-founder of Advocates for the Reform of Prescription Opioids. "The whole supply-side system is set up to perpetuate this massive unloading of opioid narcotics on the American public."

Pharmaceutical companies say the new drugs give doctors another tool to help patients in legitimate pain.

"Sometimes you circulate a patient between various opioids, and some may have a better effect than others," said Karsten Lindhardt, chief executive of Denmark-based Egalet, which is testing its own pure hydrocodone product.

Pure hydrocodone pills would avoid liver problems linked to high doses of acetaminophen, an ingredient in products like Vicodin, according to the drug companies. They also say patients will be more closely supervised because they will have to return to their doctors each time they need more pills. Prescriptions for the weaker, hydrocodone-acetaminophen products can be refilled up to five times.

Zogenix has completed three rounds of patient testing, and last week it announced it had held a final meeting with FDA officials to talk about its upcoming drug application. It plans to file the application in early 2012 and have Zohydro on the market by early 2013.

Purdue Pharma and Cephalon, a Frazer, Pa.-based unit of Israel-based Teva Pharmaceuticals, are conducting late-stage trials of their own hydrocodone drugs, according to documents filed with federal regulators. In May, Purdue Pharma received a patent applying extended-release technology to hydrocodone.

Egalet has finished the most preliminary stages of safety testing and could have a product on the market as early as 2015 but wants to see how the other companies fare with the FDA before deciding whether to move forward, Lindhardt said.

Critics are troubled because a new narcotic painkiller can lead to more murders, pharmacy robberies, and millions of dollars lost by hospitals to treat overdose victims. Thousands of legitimate pain patients are becoming addicted to powerful prescription painkillers, they say, in addition to the thousands more who abuse them illegally.

The CDC said last month that prescription painkillers caused 15,000 U.S. deaths in 2008, more than triple the 4,000 deaths in 1999.

Emergency room visits related to hydrocodone abuse have shot from 19,221 in 2000 to 86,258 in 2009, according to the DEA. In Florida alone, hydrocodone caused 910 deaths and contributed to 1,803 others between 2003 and 2007.

Opiates block pain but also unleash intense feelings of well-being and can create physical dependence. Withdrawal symptoms can be intense, causing cramps, diarrhea, muddled thinking, nausea and vomiting. After a while, opiates stop working, forcing users to take stronger doses.

"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," said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. "It's a terrific business model, and that's what these companies want to get in on."

The U.S. consumes 99 percent of the world's hydrocodone and 83 percent of its oxycodone, according to a 2008 study by the International Narcotics Control Board.

16 Photos

Painkiller deaths: 15 states with highest rates

[strawman2012]

Every blog about prescription drugs pulls in the pot argument nutballs. Weed does not cure my leg pain. Hydrocodone does. End of argument. I support legalization just you do but so much baloney on the web claiming it cures everything. It is what it is.

[djseavy]

First off, the new version is not 10 x as strong. It merely has no added Tylenol. 10mg of hydrocodone is the same whether it's pure or has the additive. Secondly, the addiction potential is the same as what we currently have. The positive side of eliminating the compounded version for some patients is that they shouldn't use all the Tylenol. It's the same old thing coming out of the DEA and FDA. Scare the hell out of everyone so that facts don't matter - fear will cover for the inaccuracies of the study.

[strawman2012]

I agree, more DEA bull-crap.

[38hazle38]

Just sitting here reading this stuff wondering why one is talking about things like magnesium deficiency, and products like MSM. Dr. Norm Shealy can explain a lot of it to you on You Tube. How about a little magnetic therapy or a tens unit.
You won't hear much about these because the Pharmaceutical companies can't make much money from you.

[truthman360]

this is why I don't pay attention to MSM, In there effort to sensationalize everything, they dont mind lying to the public, and im sick of it. Take this story for example, they make you believe that this new pill will be like taking 10 norco at the same time, and that is pure ********. the 1 pill is a time reased pill, which gives you the same amount of pain med., just insstead of taking 2 pills five times over a 24 hour period, they take one. end of story

[SmileyDave]

First of all the drug will only be made in a 10 time released, Which is the same as a Lorcet 10 and Norco 10. This will just be minus acetaminophen.
It is not 100 times stronger, how about a little responsible reporting.
Please be semi smart.

[captaincook06]

What is the problem. People have choices about their quality of life. We can't stop those who OD on meds, they will find another way to end their life and many to choose from. For those who live in chronic pain like myself, I should not be denied a med that will improve the quality of my life. For those of you who do not have a problem with pain your opinion is useless and basing your concerns from a totally different perspective. Walk in my shoes and try to smile as if all is well with the world, it is impossible. So let us make our own decisions about our pain meds, it is our issue not yours

[karek40]

and they repented not of their drug taking!

[captaincook06]

Are you a religios zealot-what does that comment even mean-

[Skitz024]

Why should they, if they are in severe pain it is not required that they "take it like a man" they should be allowed to lower their pain with medicine/drugs.

[ccvc12]

There are people who are not able to take non-steroidal anti-inflammatories. For them, this would be a godsend, regardless of the addicts who will coninue to find drugs wherever they do now. I've tried reporting people who have stolen drugs from my business and neither the FDA nor the local police chose to take any action.

[claygooding]

The police are too busy arresting marijuana users to bother with theft,and the drugs stolen from you were probably not enough for them to catch any person with any left.
If it was a large amount they would have chased them down,because then they could make a drug bust out of it instead of a theft charge,,drug charges are eligible for bounty money from your government,,whn they start paying bounty on theft charges,,the cops will be more interested.

[CentralRecovery]

There are enough brands and versions of opioids - WE DO NOT NEED MORE. We are in the midst of a prescription drug epidemic with overdoses, misuse and addiction presenting as common occurrences. If not to make money, why on earth would the FDA consider approving this medication? They fill no void in the prescribers armamentarium and would offer a new form of potent medication on which to overdose.

Mel Pohl, MD, FASAM
Las Vegas Recovery Center
www.lasvegasrecovery.com
1-800-790-0091

[realtimecoffee]

And this is not a spam advert how? Make pretty good money there at the "center" Doc?

[claygooding]

Have you ever wondered how we could be having a prescription drug epedemic?
The DEA is in control of the amount of addictive drugs manufactured by pharmaceutical companies,,so do they have the companies manufacture enough to furnish the legal prescription drugs and the black market?

[Valhalla0907]

My family was rocked by the deaths of two friends over the holidays. Both were young women in their 20's, one was a working student, the other a young mother. They both had been smoking the fake weed that is popular now, and abusing pills. I'm all for legitimate patients receiving adequate pain control, but the abuse has to stop.

[cre8iveqa4u]

I too have had very close ones die due to the OXY craze running rampant in the united states. These legal drugs kill thousands every year and they want to market one 10 times as strong and more "pure"? A lot of heroin addicts died this way when they were used to something 8% to 10% oure then get a package that is 40% pure. If the federal gov would pull thiier respective heads our of their respecttive arses and legalize Cannabis in all its forms, we would not have half as many opiate addicts in the United states. Guess how manny people have died as a DIRECT RESULT of ingesting cannabis in ANY from? In thhe past 1000 years that total has not risen abot a complete zero in all that time. Big pharmaceutical companies pay our Government huge kickbacks and the Gov makes eeveen more money "Treating" the opiate addicts where they can charge insurance over $1000 a day with little orr no succcess. Legalization of Cannabis coud and would help peoplee live longer, more pain free, and reduce cancer tumors, along with simply making cannabis users happier annd more secure from incarceration iff cannabis were legalized and taxed just like alcohol. Our national debt could be reduced by billions every year. Cannabis is over 1000 times safer than ANY drug currently on the market. NO ONE has EVER died from ingesting too much cannabis. It is impossible. Pure and simple. You CANNOT OD on pot. Yo might get sick if you ate a pound of hash, buut after thhan, you would pass out and sleep it off. Why is cannabis still schedule 1 and demonized while opiates continue killling more americans than guns? Makes no sense to me.