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FDA Panel Votes Against Recommending Zohydro for Approval


A panel of experts assembled by the U.S. Food and Drug Administration (FDA) voted against recommending approval of the painkiller Zohydro ER on Friday. The panel cited concerns over the potential for addiction, Reuters reports.

FDA officials said they could still approve the painkiller by imposing safety restrictions.

In the 11-2 vote against approval, the panel said that while the drug’s maker, Zogenix, had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone. Zohydro contains the opioid hydrocodone. Unlike some hydrocodone products such as Vicodin, Zohydro does not contain acetaminophen.

The FDA will decide by March 1 whether to approve Zohydro for sale in the United States for people who need an around-the-clock painkiller for an extended period.

Emergency room visits related to hydrocodone have soared since 2000.

“Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue,” Stephen Farr, PhD, President and Chief Operating Officer of Zogenix, said in a statement. “However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen. We remain confident in the measures we have proposed to support safe use of Zohydro ER and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population.”

In a letter sent to FDA Commissioner Margaret Hamburg, MD, before the panel vote, Steve Pasierb, President and CEO of the Partnership for Drug-Free Kids urged the agency not to approve Zohydro ER without requiring it to have tamper-resistant features. “If all extended-release opiate products were required to incorporate tamper-resistant technology, we believe that we would start seeing a beneficial societal impact of less abuse of opioid products, fewer prescription drug overdoses, and fewer deaths,” he wrote. “As a public policy matter, we should all be encouraging companies to ‘retrofit’ their current products so that they are more difficult to abuse. And we certainly should not be approving any new opiates without these protections.”

15 Responses to this article

  1. Val / September 14, 2014 at 5:59 pm

    It doesn’t take a rocket scientist to understand when pharmaceuticals are not available to drug abusers then instead they will use street drugs such as Heroin. And indeed we’ve saw the rise in Heroin use soon after Oxycontin was made tamper resistant.

    Yet chronic pain patients have as many barriers to accessing proper pain care even though most pain relievers have been made tamper proof. The whole purpose for reformatting pain relievers as tamper proof was to halt or slow down abuse. Well, if abuse has slowed down than why is just as hard if not harder for chronic pain patients to access proper and adequate pain care?

    The non-tamper proof generic version of this medicine is still available for sale to patients in Canada but not in the USA. Instead USA patients must pay for the highest cost for any brand name medicines.

    I am a health aid and I know the current cost for this medicine is over $500.00 a month with Medicare Part D. Yet it was less than $100.00 before being remanufactured.
    When are we going to put the rights of chronic care patients before drug addicts?

  2. Mystique Brent / May 19, 2014 at 10:57 pm

    I care gave my dear wife who has M.S and is still suffering after 20 yrs.
    and is now been in three nursing homes. It took me 5 years to convince her sadistic doctor. to administrate pain med.
    I had valve heart surgery that I died of from bleeding out they had to reopen me and do the surgery over again in the same session I lost 1 1/2 pints of blood.
    And after the surgery the surgeon and his team were angry at me for there screw up.
    I am transgender and they had problems with that. They with held pain meds put something on my body that made my skin feel like it was on fire for 12 hours.
    I am still in more pain than ever and have a hard time getting strong enough pain meds .
    because of the close minded doctors who need to find there compassion .

  3. Avatar of Denny doukett
    Denny doukett / April 29, 2014 at 3:31 am

    No matter how we look at any and all drugs whether it’s Tylenol to an opiate we get to a point where our bodies acclamatie to them. Even laxatives!
    The only people that should be concerned for POSSIBLE addictions is the dr. prescribing and the patient.
    I have never Dr. shopped and I have never seeked for more pain meds than perscribed. I SUUFFER tremendously EVERYDAY with pain thru my whole body and it’s not fibromyalgia! I have 2 herniated discs and 5 with no spinal fluid. I have had surgery on both shoulders that has left me with more problems than before cutting. The shoulder that was the LEAST invasive is the one that has been causing me an extreme amount of pain. I can’t sleep very well due to the fact that I can only sleep on one side but now that side has a bakers cyst in the knee and a torn ligament in my ankle. US… THE PATIENT know our bodies better than any dr.! I have brought before them any and all problems and they dismiss it as something it’s not! I know I do NOT have carpel tunnel in my right hand, the same damaged shoulder. So I talk to my ortho and she walks in with paperwork and a syringe filled with Ciortisone which I am allergic to. By the way this is another DRUG our body ends up needing more of.
    I have every symptom of Lyme disease and I have been getting progressively worse rather quickly.
    I, ME, the PATIENT had to do all the work to find out because my dr. didn’t want to look into what IGENEX was! I was told to call and find out what I need to do. So I did! I gave to pay $475 for a live blood test but at least I know what’s been breaking me down.
    I have my own PM dr. so when I address any pain the drs that don’t prescribe it to me always have to throw in that they can’t give me more. I NEVER ASK! I am there for answers and help but it just seems like all drs do now is look at every patient like they are seeking or trying to pull a fast one. I am VERY VOCAL when any statement is made like this to me. Look for the right people not to the poor, suffering patient that took the time to come get the help. Can I get an amen?

  4. Avatar of David
    David / March 5, 2014 at 10:20 pm

    i agree with person above we have except the lesser of two evils.furthermore dont forget this medicine has no acetamenophen,the liver killer thats in just about every other pain medication.I also must agree that it must be made tamper proof wich is something i believe they are already working on but please make sure its not done in a manner that takes away frome the ability of killing pain strongly and affectively.Please? My heart goes out to all and lets hope zogenix nails it.I believe they will.they can be number one.

  5. RehabCenterNet / March 5, 2014 at 10:15 am

    Zohydro is the only approved extended-release product that contains the man-made opioid hydrocodone. And while the pill is created to be an extended release, individuals could still tamper with the drug in an effort to release the medication all at once.

  6. Avatar of Steven Silz-Carson
    Steven Silz-Carson / March 1, 2014 at 6:07 pm

    Those who assert that Zohydro (hydrocodone) is “a more powerful opioid [than oxycodone] are incorrect, it is not. On the relevant (oral) equianalgesic scale, 15 mg hydrocodone = 10 mg oxycodone, thus oxy is 50% more potent in opioid activity than hydro. What’s more important however, is that unlike all the other Vicodin-like analgesics (Lorcet, Lortab, Norco…), all of which are a combination of hydrocodone and acetaminophen, Zohydro does not contain acetaminophen. Both to people who need pain relief and those who abuse these drugs, the absence of large doses of acetaminophen (aka Tylenol, APAP) is actually of great benefit. Why? Higher doses (4+ grams/day) of acetaminophen are toxic to the liver, while desired opioids are not. It takes only 8 standard Vicodin tabs to reach the FDA’s 4 gram max, that’s not a lot to someone in moderate pain or to someone experimenting in the medicine cabinet.
    60-70% of people admitted to the ER comatose with acute liver failure, had ingested too much acetaminophen. But they did so only incidentally because what they needed/wanted was the opioid in the product. About 15% of these patients needed liver transplant and a small fraction died either before or after transplantation. Armed with the fact that opioids are the only drugs that are effective in treatment of severe pain, isn’t it better that patients will have a safer choice available? And this is just as important for those who are not in physical pain, but abuse these drugs that they don’t have to kill their livers in the process of getting high? Yes, it’s a lesser of evils argument, and the lesser evil needs to be addressed too, but adding a toxin to a junkie’s fix is hardly a reasonable remedy.
    There have been alcoholics and addicts ever since humans discovered alcohol and psychotropic plants. Certainly addictions cause huge problem throughout the world, yet blaming alcohol and drugs for addiction is looking at the problem completely backwards. Our human inclinations, customs and cultures are the culprits, not this pill or that pill.
    For the record, I have no love for the pharmaceutical industry and my only connection to it has been as a patient.

  7. Avatar of Jeff Hubbard
    Jeff Hubbard / January 16, 2014 at 12:37 am

    I am currently taking 40 mg of Opana ER. Since they made them tamper proof it made the pill weaker. It takes over 2 hours for the hard shell cover to dissolve. So for 2 hours I suffer terribly from a foiled lower back fusion, right above that I have severe spinal stenosis, and bone against bone arthritis. So I am scheduled for surgery. The Dr. says to remove the metal and solve the stenosis really is two ops and since he has to do both
    hips, that’s like doing two ops. Plus I have
    MS which could complicate matters. He said that I should talk to my Pain Med. Dr. about something stronger because as soon as I awake
    I will be in misery. That is why I am checking Zohydro out. If you could recommend
    a dosage of something I would appreciate it.
    Jeff Hubbard

  8. Avatar of jpizz
    jpizz / November 14, 2013 at 8:17 pm

    As of 11/13/2013 it has been approved:

  9. Avatar of Barb
    Barb / October 15, 2013 at 12:23 am

    I agree that the prescription drug abuse must be addressed. But how is poisoning people like me who honestly need pain medicine by refusing to allow the med without acetaminophen going to help one person????

    Why not go to the source of the problem? These drugs are not being stolen from pharmacies, not being made, but being prescribed. And stolen from medical facilities. I have seen that first hand. Dr.’s are not being held responsible. I have been present when people called their Dr. wiht “I dropped my pills and they fell in the sink”, “I was at my uncles beach house for the weekend and now I am home and can’t find my medicine”, “I got home from the drug store and the neighbor asked me to help him and when I came back the dog had chewed up the bottle”. And this was in 1 (ONE) month. And yes, some of the 4 fills where for sale.

    The police can’t do anything about the Dr. I certainly can’t. The person who was stealing from the medical facility – “We have no reason to believe that X would do anything like that.”

    Many Dr.s are opposed to prescribing Hydrocodone /acetaminophen because it is the “leading cause of acute liver failure from unintentional acetaminophen overdose.” So they use the Oxycontin which is far more addictive and doesn’t work as well.

    It is truly sad that all the effort you are making will not help but make it worse. You are alienating a large group who would support you if you weren’t harming us.

    Show me the drug addict who cares about how much acetaminophen is in Vicodin and I will get you lots of new contributors. Although it’s not as stupid as the cancer people getting more cancer-causing chemicals in the cigarettes so some people don’t die in fires (so they die of cancer and we get more federal money!)

    Btw- It’s your tax money that pays for the liver failures. It pays for the kidney failure I have from being prescribed up to 3 NSAIDs at a time with blood pressure over 170 – because “narcotics are not safe”. Yet I had no kidney damage and was working fulltime while on narcotics for almost 20 years – the same dose as well. But it took less than a year to destroy my kidneys and now I can not work at all. Personally I would rather you had kept your money and left me my health!

  10. Avatar of Joe Rosado
    Joe Rosado / August 30, 2013 at 1:04 am

    In 2004,I believe the FDA, passed a measure for an across the board reduction of all medicines, ESPECIALLY OPIOIDS, used for treatment of patients with various pain disorders because there was an escalation in acetaminophen overdoses and organ damage especially the liver, and that all pain meds were to have no more than 200-325 milligrams of that garbage. It is garbage. I dislike all these negative fear mongering connotations and tactics that are now used in medicine today that punishes doctors and patients. Is it truly the fault of several million severe and chronic sufferers of cruel,unwavering,sadistic pain that all this hysteria is rated a number 10 on a scale of 0-10. Groups of angry citizens whose loved ones passed or developed “addiction” all of a sudden because of something Dr. Oz said. How many times I’ve been called drug addict by so called professionals so I could quote them New England’s Journal on “dependence,tolerance,and addiction” and shoo,shoo,hush,hush, you imbecile. Even Pharmacists with condescension in their tones question my doctors prescribing method or the meds themselves simply because they can and they’ll tell you I don’t have to fill this. Don’t Bitch. Gimme my script have a fucked up day.
    We now have SOME advocacy for ending some of our misery and a bunch of nosey people think they have a Sanctimonious right in detailing the construction of the meds. GO HOME. CLEAN OUT YOUR OWN CLOSETS. How many other medications including Tylenol,ibuprofen, heart meds, liver meds,etc. have killed patients. Where are their Advocates? And, you don’t have a right to pain medicine, constitutionally, that is, so I’m told.
    I will be the first one, if welcomed to try Zohydro, accompanied by a regiment with a Doctor, because OPIATES,THANK GOD, HAVE SAVED MY LIFE, MARRIAGE, RELATIONSHIPS. They have been the CONSTANT in Modern Medicine, and war time, to SAVE lives, not DESTROY, for millions. Opiates help me get out of my bed, walk with my canes, drive my car to my doctors. Write this long commentary

  11. Avatar of Chris
    Chris / July 25, 2013 at 5:35 pm

    What is the current status? Is it off the table?

  12. Avatar of carol
    carol / July 11, 2013 at 9:06 pm

    I currently cannot do anything normal like wash clothes dishes play with my son etc. I am ihn pain 24 7 xometimes a 5 sometimes a 10. I take the ax dose of hydro 6 a day of the 10/500. The oxycodones and others do not help. I have been hoping and waiting for the hydros without any ibruprophen or tylebnol so I could take more. Please pass this to whoever needs to read so I can at least start doing a little around my home.

  13. Avatar of sherrill
    sherrill / March 7, 2014 at 10:55 am

    I agree i have so many days i am in pain i to cannot do any chores on a daily basis and can not ever go back to work so this pain medicine would be great think about the people that are not abusing their meds.and are just looking for something that will work i cant enjoy my life cuz i am in constent pain 24-7 as well

  14. Avatar of rocky benwah
    rocky benwah / March 19, 2014 at 10:40 am

    THANK YOU!! People out there looking for a high are going find a way to get high!But for millions of people, like me, we depend on these medications to function. I have been using opiods since 2000 for my chronic pain. I am NOT an abuser. I am NOT addicted. I am DEPENDANT. Without these meds I am useless with no quality of life once so ever. I have given up everything I enjoy due to chronic pain. I am to start this new treatment this week. Although cautious, I am hoping for better pain relief!

  15. Mystique Brent / May 19, 2014 at 11:12 pm

    thanks the same for me I cant clean and iof I do something one day the next day I have to stay in bed all day to recover.
    some days I wish they would have left me to go to my God .
    Its not being alive its the quality.
    WE have to stay on top of this. I see many people who cant get satisfactory pain relief .
    because they don’t have cancer which is the preferred pain medicine disease .
    Looking other places for pain relief .
    I don’t even know where to buy pot.
    But if things get bad enough they are going to send good honest people in there sixties and older looking for the white lady for relief. The medical profession and law enforcement think they have problems now. They are driving us straight to other not so preferred ways to deal with something which is legally do able. This is not living

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