Attorneys General Want FDA to Reconsider Zohydro

Attorneys general from 29 states have asked the Food and Drug Administration to reconsider its recent approval of Zohydro, a powerful new extended release painkiller.

In a letter sent to FDA Commissioner Margaret Hamburg, the attorneys general said they did not want a repeat of the past when narcotic painkillers entered the market without tamper resistant formulas. Drug abusers learned they could crush or liquefy painkillers such as oxycodone to snort or inject the drug.

Zogenix-Zohydro“We believe your approval of Zohydro ER has the potential to exacerbate our nation’s prescription drug abuse epidemic because this drug will be the first hydrocodone only opioid narcotic that is reportedly five to ten times more potent than traditional hydrocodone products, and it has no abuse deterrent properties,” the letter says.

In October, the FDA ignored the advice of its own advisory panel, which voted to reject Zohydro because of its potential for abuse.

“If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” FDA staff reviewers wrote in a report.

The FDA, which is not required to follow the recommendations of its advisory committees, did not require that Zohydro be made with a tamper resistant formula.

“Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids,” the FDA said in a statement.

Zohydro will be classified as a Schedule II drug, which means it can only be dispensed through a physician’s written prescription, with no refills allowed. There are also more stringent recordkeeping, reporting, and security requirements for Schedule II drugs. In October, the FDA recommended reclassifying all hydrocodone products as Schedule II drugs.

Hydrocodone products such as Vicodin typically contain acetaminophen, which is a leading cause of liver failure in the U.S. Nearly two out of every three acetaminophen overdoses are attributed to hydrocodone-acetaminophen products. Vicodin is the most prescribed medication in the U.S.

Zogenix (NASDAQ: ZGNX), the San Diego based company that makes Zohydro, claims its new drug will actually be a safer formulation of hydrocodone because it does not contain acetaminophen.

The company says it is developing an abuse deterrent formula for Zohydro and was “committed to advancing the program as rapidly as possible.” In February, the company said it was “a few years” away from developing such a formula.

In their letter, the attorneys general said they wanted the FDA to set a “rigorous time line” for Zohydro to be reformulated.

“The approval of this very potent drug is troubling because, unlike extended-release opioids containing abuse-deterrent properties, there is nothing that would prevent someone from easily crushing or injecting Zohydro ER to get high,” said Kentucky Attorney General Jack Conway.

“For decades, we have fought the disastrous effects of the illegal marketing of the drug OxyContin. Zohydro ER has the potential to exacerbate the prescription pill epidemic and given that abuse-deterrent properties are capable of being developed and required, the FDA’s decision to approve the drug doesn’t make sense.”

Purdue Pharma reformulated OxyContin in 2010 to make it more resistant to tampering.

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12 Responses

  1. JNR says:

    WHAT A PERFECT DARWINIAN SOLUTION TO THE EXPENSIVE PROBLEMS OF THEIR CRIMINAL ACTS, PROSECUTION, INCARCERATION AND/OR TREATMENT OF ADDICTS!

  2. karester says:

    Lots of smart comments here. The FDA and Big Pharmas have had to back down from the Purdue ER pills because so many addicts are dying from trying to run it. They freeze it, then microwave it?????… basically, an addict will find a way, no matter how it’s formulated, how costly, how difficult to obtain or how severe the punishment. Take away safe, manufactured drugs and we have a heroin epidemic on our hands. I do not want heroin available to my grandchildren in middle school.

    How many times must history repeat itself before we learn from our past? Prohibition does not work. Our prisons are packed with non-violent offenders. The acetaminophen is killing me. The warning on an OTC bottle states, do not take for extended periods… I’ve been on it for 5 years.

    YES!!! Let us be adults and make our own choices. Let me be an active participant in my social and familial circles. Without narcotics I am stranded in bed.

  3. Renee H. Ritchie - Gazarkiewicz says:

    WAIT WHY WASNT THIS PROBLEM ALL TAKEN CARE OF WHEN THE MAKERS OF OXYCOTIN WAS SUED?? THEY PROMISED BACK THEN THAT THEY WOULD HAVE IT RESOLVED IN A YEAR OR SO.

    This problem I thought was suppose to be taken care of by the manufacturers of Oxycotin before they pulled the bigger dosages used for cancer patients off the shelves. Weren’t they going to put an anti antagonistic drug in them to keep them from crushing them & snorting, chewing, or shooting them up?? Why Couldnt they put narcon in them? Crush cut the pill good the

    Another problem is that all the old pain medications had on the market today the so called drug studies were done on Men only!! Medications dont always work the same on men & women. Are new studies for pain management medications useing WOMEN in thier studies & clinical trials ??

    They me on 90mg ER Morphine every 8 your with break through med every 4 hour. All that the ER morphine did s suppress my breathing & one day I black out for 6 hours no idea of where I had been. What I had done. I was driving my car I got out & walked around it wondering if I had hurt anyone???

    I called for someone to come & get me & my car. I then called my doctor & told him get me off. Of this drug now!! He weaned me off of it & we replaced 90 mg. of ER morphine with 20 of oxycotin three times a day. I have diverticulitus so a lot of extended meds dont stay in my
    body long enough to work.

    So recommend dosing doesn’t always work for every patient either. So then people like myself have to fight like tooth & nail with the Insurance company over more than the ” recommend monthly supply by the government”. The they go to School & get a Medical Degree & get licenced in my state then they might recommend my dose if I hired them as my Dr. We are not like rubber stamps made in a factory we dont absorb the medications the same or at the same rate. Like myself the pills normally dont stay in me 12 hours so how are they going to work 12 hours? Many true Chronic pain patients get a bad rap for a few bad ones & a lot of junkies. Believe me they would of round something to get high on if they want it bad enough.

  4. Chris says:

    Jail monies and commissary sales are gonna break all profit records$$$$
    Cha Ching yeee haw!!! Big Pharma profits sky rocket !!! 700 billion a yr!!!
    Addiction and ER visits will increase
    Rehabs are gonna make allot of money!!!
    Tax payers are on the hook for law enforcement
    Courts and jails housing these addicts
    More auto accidents!! More job injuries!!!
    Lawyers live for this !
    $$$$$$
    It’s all about the money – Suckers
    Jeepers Creepers
    You think it’s bad now
    You ain’t seen nothing!!!!
    Wait til the high school kids get a hold of this new oxy
    Look out!!! It’s a coming
    Corporate profits rules!!
    You don’t count
    Casualties of Profit
    Move over or get run over!!!!
    FDA gets bought again!!!
    Suckers !!!!!!

  5. denise says:

    I understand addiction…there are siblings of mine with mental health issues that abuse…..however….having said that I suffer from chronic pain. I used to work hard, managed a store in the mall, then at real estate office, worked for a mental health center working with kids. I went to college, got 3 degrees in 4yrs. so I know what work is…so everyone was shocked when i went into doctor and said i could not do it anymore, by then i was crying he gave m morphine right then and this was at a Naval base….and i have NOT had that compassionate of a doctore since and its been 12yrs. i just want a medicine that WORKS that give me RELIEF for at least 12hrs…i dont want to have breakthrough pain….my doctor now gives me 15mg morphine long acting so i only get it 2 times a day…i am so sore especially days like this that i am bed ridden! THIS SUCKS!!! let us decide if we want to use that med. Because i gaurntee the addicts will figure out what ever u use to block it….ok this is too long sorry…im for the drug not for others telling me what is good for me and what is not…

  6. Pedro says:

    If you are going to reverse the approval of Zohydro ER then you may as well pull Fentanyl, Morphine, Opana, Vicodin and Percocet off the market. Otherwise you are doing absolutely nothing to address the careless prescribing of addictive narcotic pain medication, which I believe is the real problem.

  7. Dennis Kinch says:

    Hat’s off to the FDA for letting us be adults, whether good or bad, wrong or right. Another step towards freedom…from pain and from our laws.

  8. Trudy McGee says:

    Problem is that drug addiction is a disease which is just as serious as chronic pain. Mental health is NOT being addressed in this country to the point that most people cannot even access the mental health system. Even with the affordable health care act, mental health is still expensive. To top everything off, it is still considered a weakness of personality. Mental health is just as necessary as blood pressure, diabetes or chronic pain. They all kill. When people start realizing that we have to take care of each other from before birth to death, and not “skip” parts, that is when this country will have achieved success. Until then, we are merely putting out fires, nothing more and nothing less. It just causes useless suffering.

  9. I think all drug smokers, junkies, tweakers, and alcoholics should be rounded up, locked up somewhere, and given as many free drugs as they want until they do the world a favor and die. I remember hearing a case in Philadelphia of junky scum dying from heroin laced with rat poison, I applaud the man who made a small contribution to the cause of purging drug addict virgin losers from the earth.

    Seriously losers, just go out to a club, have a few beers, get laid, don’t whine all day about how awful your life is and be even more of a coward by covering it up with addictive poisons.

  10. Wendy says:

    This is so disheartening. I agree with what Steve has said, in terms of the abuse deterrent formulations not working as well for pain patients.
    Is there a way to address these AGs? Which states are they from? I would like to know.
    Pain as a disease or chronic pain is not well understood or treated by many in the medical community; how is we think those in law enforcement have an understanding of it? They don’t. They know law enforcement and legal speak. They only interact with people who use these meds when there is a problem with abuse, therefore there must be an epidemic. Yikes.

  11. Kimberly Miller says:

    The FDA, DEA, and fame-seeking attorneys general such as Jack Conway, slated to run for governor of Kentucky next year, have done all they can do to keep chronic pain patients from receiving adequate relief by restricting access to opioids.

    By intimidation tactics directed at medical providers, treating pain patients as criminals by requiring monthly appointments, urine drug screenings, and random pill counts, and continuous media reports containing exaggerated numbers on overdoses and prescriptions written, what more can be done? I guess, stop any new medication with the hope of helping chronic pain patients.

    None of these other tactics have stopped drug addicts in their downward spiral. They merely make people already suffering hurt even more.

  12. Steve says:

    Addicts will find ways to abuse drugs, period.

    These abuse deterrent formulations don’t work as well for pain patients. They test them on healthy people, but chronically ill people already have trouble absorbing drugs.

    My wife gets more relief from 15mg 4x/day OxyIR (60mg/day) than 80mg new OxyContin 3x/day (240mg/day). She doesn’t absorb it like plain oxycodone or original OxyContin. Same problem with Opana ER. We didn’t even bother with Exalgo.

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