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Zohydro to be Manufactured by Same Company That Makes Addiction Medicine

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The newly approved pure hydrocodone product, Zohydro ER (extended release), will be made by the same company that manufactures Vivitrol, a drug used to treat patients addicted to opioids or alcohol, The New York Times reports.

The Food and Drug Administration (FDA) approved Zohydro ER last month for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. Drugs such as Vicodin contain a combination of hydrocodone and other painkillers such as acetaminophen. Zohydro is expected to reach the market in early 2014.

In December 2012, a panel of experts assembled by the FDA voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction. 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.

In 2010, Zogenix bought the right to market Zohydro in the United States from another company, Elan, the article notes. The following year, a company named Alkermes, which makes Vivitrol, bought a unit of Elan that included Zohydro. The deal included the existing agreement with Zogenix.

Alkermes provides financial support to the American Society of Addiction Medicine, a leading professional group representing substance abuse experts, according to the newspaper. Dr. Stuart Gitlow, president of the group, told The New York Times he had been unaware of Alkermes’s involvement with Zohydro, adding the group would ask for more information from the company and then decide what, if anything, it will do about the situation.

Some law enforcement agencies and addiction experts have voiced concern that approval of a pure hydrocodone drug will lead to an increase in overdoses.

12 Responses to this article

  1. bill / July 1, 2014 at 10:24 am

    I would love to try it, but im prescribed to 180mg of oxycodone a day for back pain and broken ribs. I started with hydrocodone (Norco) 10/325 and I really liked them and still do but compared to oxy they are nothing. Now methadone, that is better than oxycodone in my opinion. It is the ultimate pain killer. I like it better than shooting heroin. So when I get off oxy I plan on getting on methadone because I have subutex but it doesn’t really help with the pain. When I tried methadone I was floored. I was in heaven. Subutex makes you feel good when you take it the first 4 days then you feel nothing.

  2. Brian / June 24, 2014 at 11:40 pm

    I’ve been in chronic pain for three years now, ever since a guy using is phone rear ended me doing 55+mph while I was stopped at a light. I have had 2-back surgeries and countless other procedures with little relief. For the last 8 months it has been unbearable. It took a longtime for me to get into a pain doctor. Very strict good pain doctor. They do pre-screenings, thorough first visit, UA’s, and counseling.

    He took me off of Tramadol ER 300mg which wasn’t touching it and he put me on Zohydro 30mg every 12 hours, for two weeks now. This drug isn’t cheap, the doctors sport’s aren’t cheap. I could buy three to four times the heroin for the price of one script with insurance. So leave the drugs alone, if people OD and die so be it. All I know is for the first time in over a year have I been as comfortable as I am. I still have pain all the time, but it is reduced a lot.

    Let the doctors help who they are suppose to, us the chronic pain sufferers.

  3. Uilleam / June 9, 2014 at 11:12 pm

    What is the fuss? In Europe until its withdrawal last year, we had DICODID, pure Hydrocodone, marketed NOT as an analgesic (it is actually quite weak – it is the acetaminophen in the US product that causes damage and takes lives – ) but an antitussive. As far as I am aware there are little or no recorded deaths from its use.
    You anti-hydro folks should get facts right. It is a useful, mild opioid which is exceedingly useful but the US practice if adding dangerously high quantities of one of the most hepatotoxic drugs we know of, but which remains on open sale despite it being one of the most dangerous and life taking drugs known to man, is the problem. I for one wish that Hydrocodone, 1.5 x the strength of dihydrocodeine, its parent drug, was available for mild pain in the UK. We have Oxycodone for more severe pain but lack anything but the relatively dangerous tramadol in between codeine and morphine in strength.
    You should be highly pleased that acetaminophen is out of the equation. The only reservation I have is that in an SR formulation it will prove too WEAK. The effective dosage of dihydrocodeine for me is 80-90mg, equivalent to immediate release Hydrocodone of around 50mg. Anybody with any sense who really wishes to dispel mild to moderate pain will have to find a way of circumventing the SR system which only allows a very small dose of this extremely safe mild opioid into the blood at any given time, and with the liverf*ck containing pills! taking effective dosage can be life threatening.
    Get real.

  4. Avatar of Jessica
    Jessica / May 7, 2014 at 12:10 pm

    I suffer from chronic pain and took opiates for 9 years. I argued that they were the only thing that helped me and I wouldn’t want to live with the pain without opiates. Now I’m completely opiate free and use cannabis to control my pain. I finally have my life back. The opiates had made me withdrawn and never felt like leaving my room. I’ll never use opiates again! I encourage everyone to look into medical cannabis. You don’t have to get high and be a “stoner” you don’t even have to smoke it. Cannabis can dramatically improve your lives!

    • TexasTammy / July 4, 2014 at 10:32 am

      I am lucky that I have a doctor who understands the pain I am constantly in. After 3 back surgeries and at least 6 or 7 other surgeries, it hurts me just to walk around! I’ve tried the therapy, massage, acupuncture, steroid injections, etc. and nothing works except the pain medicine that I am on now. Sometimes even that doesn’t work!
      I wish cannibus would be legal in my state because I would sure try it. But, I am not going to be put in jail for using it while it is still illegal! In there, I don’t believe any pain medicine would be available!
      As for this new drug, Zohydro, I am going to ask my doctor at my next visit if I can try it. I sure hope he will be agreeable. Right now I take Oxycodone and Oxycontin. We will see what happens!

  5. Avatar of Laurie Liberty
    Laurie Liberty / May 5, 2014 at 4:40 pm

    This is crossing the line of PROFESSIONAL ETHICS….What human is going to guard this from innocent humans being exposed…. Sorry No human that cares for other humans would ever say this is ok to be in the public…………… SHAME and lives will be on your heads……..RESPONSIBLE parties for putting this in the hands of the public and in our world. Shame on you all…..PILLS KILL and the reason you have so much pain and no care for others take some more pills………SORRY FOR YOU BEING SO CARELESS and effecting others…Take your pills maybe you will get what you want no more pain…Just wrong to be able to kill with one dose…MY OPINION MY RIGHT….

  6. Avatar of Zorbitor
    Zorbitor / April 26, 2014 at 1:08 pm

    I’m just gonna say it: I don’t care how many recreational addicts die or what their age is. I also don’t care if drinking and taking these pills kills them.

    The idea that THEY drive our policy regarding these drugs is hysteria and amounts to nothing less than cruel and inhumane treatment for the people who have no choice and legitimately need them. But the number of pain doctors is far less than the number of war-on-drugs cops, lawyers, corrections officers, counselors with masters degrees selling 12 step religion, holistic healers, and politicians.

    America this is no way to treat your suffering children, parents, and the elderly!

  7. Avatar of Patrick
    Patrick / April 16, 2014 at 1:42 pm

    It’s absurd for them to worry about a few addicts that are going to get any drug they can to abuse i suffer chronic pain and wouldl love on pill to help me get threw it

  8. Avatar of Jim Ellis
    Jim Ellis / April 11, 2014 at 12:40 pm

    I am a long time addict and I am amazed to see that we are in control of how opiates may hit the market. I have been in recovery for some time now and I cant believe that they are more worried about if us the addicts will be able to get high of of this new med. Instead of worrying about the people that may really need this med that dont misuse drugs. Only in America..

  9. Avatar of Jerry
    Jerry / March 19, 2014 at 10:28 am

    As far as the whole “abuse deterrent” designs are concerned…. Those are a falsification put in place to make the average person feel more comfortable. Any addict with just a TINY amount of effort can thwart ALL “abuse deterrents” on the market today.
    So, my main question is this: why should law abiding citizens be denied access to medications which may be the ONLY source of semi-normalcy they are EVER able to obtain just because some drug addicts choose to misuse it?
    The laws in this country sometimes baffle me. What rational minded group of people would EVER say, “Let’s punish the good people in an effort to make things a LITTLE more difficult for those that break the law.”
    And as ANY long-time drug addict will tell you, oxycodone feels MUCH better than hydrocodone ESPECIALLY since it takes FAR more than 50mg of hydrocodone to REALLY get going…. Senator Manchin (West Virginia, I believe) is demonizing this god-send of a medication in order to get it ripped out of the hands of people who REALLY need it… This is nothing more than a corporate ploy to destroy their competition… Look into who Senator Manchin’s daughter is…… She is the CEO (I believe that’s her title) of Mylan Pharmaceuticals…. You know, Zogenix’s competitor… This is a PERFECT example of how American Politics fails the people!

  10. Avatar of Craig
    Craig / April 4, 2014 at 9:36 pm

    Jerry….you took the words right out of my mouth. So many people actually need medications like this in order to just get through the day without being in excruciating pain. And for government reps to decide weather or not it’s ok to obtain these types of medications is absolutely ridiculous. Being someone who has had multiple surgeries due to an IED I came across in Afghanistan, I take 30mg of oxy 4 times a day and sometimes that isn’t even enough to dull the pain in my back and legs.

  11. Avatar of julie
    julie / May 6, 2014 at 10:42 am

    Those recreational addicts” that you want dead is a friend,mother, brother sister,of someone ,your comment contradicts everything,

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