Senators Warn About Zohydro as Painkiller Nears Launch

Senators Warn About Zohydro as Painkiller Nears Launch

Three U.S. senators are raising concerns about Zohydro, a new extended release painkiller that will be introduced next month by San Diego based Zogenix Inc. (NASDAQ: ZGNX).

Republicans Mitch McConnell of Kentucky, Tom Coburn of Oklahoma and Lamar Alexander of Tennessee sent a letter to the Food and Drug Administration asking how the agency will prevent the misuse and abuse of Zohydro, which will the first pure hydrocodone painkiller sold in the U.S.

Zogenix-ZohydroThe FDA approved Zohydro last October over the objections of its staff and advisory committee, which warned there was potential for Zohydro to be abused even more than currently available hydrocodone combination products.

“Given this clear warning from the FDA’s advisory panel, we would like to know what safeguards FDA mandated for the product,” the senators said in the letter to FDA commissioner Margaret Hamburg.

Combination versions of hydrocodone, such as Vicodin, typically contain acetaminophen and require dosing every 4 to 6 hours. Extended release Zohydro could be taken just twice a day for chronic pain.

Zohydro will be classified as a Schedule II drug, which means it can only be dispensed through a physician’s written prescription, with no automatic refills allowed. There are also more stringent recordkeeping, reporting, and security requirements for Schedule II drugs.

In December, 29 U.S. Attorneys General wrote to the FDA asking the agency to reconsider its approval of 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.

This week Zogenix said is was preparing for Zohydro’s commercial launch in early March. The company said the painkiller was ready for shipment to wholesalers and that adequate inventory is in place to meet anticipated demand for the drug.

Zohydro is being introduced without a tamper resistant formulation to discourage drug abuse. Addicts often crush or liquefy painkillers such as oxycodone to snort or inject the drug.

Zogenix is developing an abuse deterrent formulation for Zohydro. In 2013, the company said it was “a few years” away from developing such a formula.

The company claims its new drug will actually be a safer formulation of hydrocodone because it does not contain acetaminophen – which can lead to liver failure in high doses.

“For patients managing chronic pain with an immediate release hydrocodone combination product, an extended release formulation without the risks associated with acetaminophen may be beneficial. Zohydro ER may also be an alternative for people living with chronic pain who have developed opioid tolerance or are experiencing side effects with other long-acting opioids,” the company said in a statement.

Zogenix also announced the formation of an independent “Safe-Use” advisory board to give the company feedback and recommendations regarding the use of Zohydro after its launch. The board will meet regularly to review data about the medication’s prescribing and use.

“This type of voluntary initiative on the part of Zogenix, will allow external, highly experienced specialists, to provide valuable insight and advice about the impact of introducing this new pain treatment to the community and, if needed, to recommend specific actions needed to ensure that the risk of abuse, misuse and diversion is minimized,” said advisory board chairman Jeffrey Gudin, MD, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center in New Jersey.

Authored by: Pat Anson, Editor

There are 13 comments for this article
  1. dave at 12:17 pm

    As the saying goes: It is better to light a candle than curse the darkness. People in pain have many options to be heard and receive more effective and more humane care. They can create or sign online petitions, they can take a survey like the one on this site and on other pain advocacy organizations. They can become a member of pain advocacy organizations. They can petition their state and federal legislators.
    When I look at the membership of organizations for breast cancer compared to chronic pain- it is plain to see that many more people with breast cancer have signed on as members of breast cancer than pain organizations- despite the fact there are probably 40 times as many Americans in pain than there are Americans with breast cancer.
    So if people in pain want change they can and should join organizations involved in pain care, petition their legislatures, sign onto petitions and become more active politically.

  2. Kim power at 3:40 pm

    As a medical professional and a chronic pain patient, I am tired of hearing about the drug abusers. There will always be meds to abuse. If they want to get sober it doesn’t matter what drugs are out there. If they want to use they will find a way. I also have experience with addiction in my family and he is sober and clean regardless of what I take. These addicts are responsible for themselves just as I am. I can’t find a pharmacy to fill my pain med script which I have been taking for a long time and receiving from a legit pain doc for the same amount of time. When I finally find a place they charge me over 800 dollars. Our system is very messed up. I should never be turned away with a legit script that can be verified. I’m tired of taking the blame for others. Why don’t we help all the patients that can’t get their meds? Talk about discrimination and cruel and unusual punishment, we are living it.

  3. wolflady at 11:18 am

    what does it matter doctors won’t prescribe Sch. II anyway so what good is it to approve something that Chronic Pain sufferers will not have access to just like the pain medications already available. I suffered liver damages years of tylenol laden hydrocodone that only reason od in tylenol is abuse prevention. How nice to know the government would rather kill me then heaven forbid abuse a pain medication. Maybe if I hadn’t been called drug seeking with imaginary pain, I wouldn’t have unbearable Chronic Pain thanx to ignored serious medical problem visible on first c-scan but being a drug seeker, noone bothered to look for medical reason for my Pain, & if the infection had been found a year early, I would not have been 3 days from death crawling on the ground unable to stand, and suffering in Unbearable pain for over a year then months of hosptital getting rid of infection, and another year of recooperating, walking again, and left with permanent damage & Pain all avoided if not labeled a druggie.. And if the first time wasn’t enough, doesn’t matter that I nearly died while being accused of drug seeking, but you think my suffering would have at least earned me the decency of believing when I say I’m dying with pain, but NO, amazing, as I again accused of drug seeking, & pain meds cut off, no diagnostics, & crawling into ER with ER doc, slamming 5mg. of demerol in my ASS w/ an Yeah Sure heres your drugs now get lost, UNTIL ULTRASOUND SHOWING A BASKETBALL SIZE MASS IN PELVIC AREA, had him singing a different tune & appology not accepted when GP comes to my hospital room Sorry for Calling me a Drug Addiict & not even trying to diagnose my pain. And once again, surgeon causing the infection refuses to see me when I call stating Pain is worse not better, and refuse to give her the pain meds I bought to get stronger prescription, & even longtime Specialist the only one believing me last drug seeking accusation, let me down this time, & even worse then suffering for a month with infection growing and no one listening, then a Year trying to get damage caused by quack with a laser repaired, but as I am forced to live in Doctor Caused Hell when f inally after years of suffring pain managed & Understanding Doctor is taken from me, forced to ER where Some LOw life Dirtbag has the nerve to Tell me he will not treat my pain when last resort pills after months of dying in pain & desperate for a break, , & has the nerve to me like Iits my fault & and destroyed my life & not even bothering to look at the 100s pages of medical records documenting every reason I am in pain including surgeons observations extensive damages inside, & barely recognizable parts from deformed from damage, & on and on,

  4. pharmaciststeve at 8:20 am

    @Dan… .. first of all Zohydro ER is going to be available in SIX different strengths.. 10,15,20,30,40,50 and it designed to last 8-12 hrs. Currently that high a dose cannot be provided without messing up someone’s liver.

    Secondly.. Methamphetamine is still available as a C-II drug.. for ADD/ADHD.. and back in the 60’s-70’s is was made by Abbott Labs and brand name was Desoxyn.. and was used as a diet aid.

  5. Donna Ratliff at 10:08 pm

    Unfortunately, many patients have bad reactions to the abuse deterrent types. I think it’s about time for another pain med to come out for legitimate pain patients. I will bet this med will produce some much needed relief for those who get it prescribed. When is it time for the FDA and govt. to start worrying about effectiveness for pain instead of abuse all time? Ok so some people abuse but does everyone have suffer because of that minority? I am anxious to hear the feedback from this med especially because it’s original and has not been altered to ineffective relief as the others. The deterrent just don’t release the medication correctly as they once did. The milligrams time released per hour isn’t there.
    I wonder how many long time pain patients (8 yrs or longer) agree that Oxycontin and Opana are not nearly as effective as they once were. There has be some medicines available that work for these patients.
    I talk with many of chronic patients daily.
    I am also truly sick of hearing about poor addicts, just as the other posters here.
    Pain patients deserve better relief and for many reasons since 2011 they aren’t getting it anymore. Access issues are constant problems.
    So this will interesting for me learn.

  6. Nicole at 6:40 pm

    It is SO EASY to pass judgment on people with chronic pain. The truth is that through educating myself and spending a full week at the Mayo Clinic this year, I was able to get off 3 medications but I do still take pain meds daily. The pain never goes away. I don’t like feeling foggy or the “drugged” feeling but if I don’t take pain meds to take the pain down to a tolerable level, I absolutely cannot function! I would not be able to keep my full time job and would be forced to be on disability like many people with my condition. If that happened and I was always in pain, I too don’t think I could honestly survive! Chronic pain effects all areas of our lives! Once the pain gets above a certain level (which I’m sure is different for everyone) it effects my mood (very impatient, irritable, angry – which is NOT my normal character!) It causes severe muscle tension all over my body which spikes my pain level to an unimaginable level. My head feels as if it would explode as the muscles tense throughout my body and I’m unable to relax them. Next I am unable to handle many sensory things – I have to turn down the lights, remove myself from all noise (talking, laughing, singing, music… even the fan blower on a heater can get to me.) Then my skin feels like it’s on fire – an electrical type burning sensation where I want to rip all of my clothes off! It goes on and on. Without using the pain meds I have, I just wouldn’t be able to go on living. In addition to getting off 3 meds that were unnecessary &/or harmful to my body, I changed my diet by going gluten free which has helped me to lose 30 pounds in the past 3 months, I’m having more “good days” and as soon as this frigid weather passes should make it easier for me to use less and less of the pain meds. You see, people who need these meds to manage their chronic pain aren’t usually the ones who end up abusing them! Often people who have an acute injury and only need something for a short period of time are the ones who use it to “feel good” or whatever…they end up abusing it by taking more than they need for longer than they need. NOT ALL PEOPLE but I think many do…at least many more than people with chronic conditions. That’s my take on it. I’ve been “judged” by people who know I’m on this pain med…but also Dr’s who don’t know or understand my condition…and even an old pharmacist who has no right to do so and should know better! My dr knows that I would rather take less medications and that I am always researching things that will help myself feel better and asking if I tried THIS could I eventually get off of THAT…and we discuss all options. I’m lucky to have this Dr because I was treated like it was all in my head for over 20 years of my life before finally getting diagnosed in my late 30’s. And guess what…I was the one who asked my Rheumatologist if it could POSSIBLY have this condition (after researching because I was struggling to even keep up with my life…I was ready to file disability but refused to as I had a toddler at the time who deserved a fully-functional mom.) THEN he tested me and I was diagnosed. So please stop judging people with chronic pain. We would do anything to get rid of our conditions. I research almost daily new ideas, options, dietary changes etc. that I can do to naturally help myself. I deserve to live a good life. I deserve to be pain free. I deserve to provide a good life for my child. I deserve to not suffer more than I already do every single day. Please go criticize something you know more about…maybe then your opinion will count! To all my fellow chronic pain sufferers, I pray we all will find ways to improve our quality of life! If we choose to use medications to manage some of it, and it helps, then we are doing the right thing! <3 Blessings to all!

  7. dave at 3:57 pm

    Dan- your barking up the wrong tree- people in pain dont force doctors or researchers what to do-and it is doctors and researchers who have failed people in pain. Someone in pain cant say to the average doctor- gee id like some Manaka acupuncture for my bursitis- or how about a little frequency specific microcurrent for my osteoarthritis. It is unfortunate that too many people blame people in pain for the sorry state of affairs in pain care- when they are the victims of stigma, doctors having no education in pain care and politicians going along to get along with pharmaceuticals companies wanting people in pain to take opioids. Maybe you should write your member of Congress and ask them to require all doctors to have education in pain care and make intelligent use of nonpharmacological treatments. Maybe you could write Dr Landis of the NIH pain consortium and tell her to focus on nonpharmacological solutions for people in pain instead of her interest in biomedical pain mechanisms( shich is predicated on creating more drugs for pain). But Dan- frankly people in pain have almost no say over the treatments they receive-they are essentially treated as surfs without rights. And I am not someone in pain- I am a social worker who helps people in pain almost every week for the last 4 years. And furthermore, I am not a fan of the current focus on opioids for pain.

  8. Dan at 1:26 pm

    Ok, not to sound unsympathetic to people in pain, but this is getting a little ridiculous. There’s a difference between taking all pain medication away and not allowing at 5-10 times stronger pill with no real abuse deterrent to hit the market. America is in the middle of a huge prescription drug abuse epidemic. Americans, who account for 5% of the world’s population, also account for 80% of the world’s opiate consumption and 99% of its hydrocodone consumption. Also, deaths related to prescription drug overdoses have quadrupled since 1999. There is obviously a huge disconnect here. The logic “Its ridiculous to worry about abuse-their[sic] is meth, cocaine and heroin and alcohol-it goes on and on…” is in itself ridiculous. Especially considering In 2010, more people aged 12 and older abused or were dependent on prescription painkillers than cocaine, heroin, stimulants, and sedatives combined.
    Not to mention the fact that doctors don’t write you a prescription for Meth, the FDA didn’t approve Meth for human consumption, and big drug companies aren’t lining their pockets with Meth money(at least not openly, but I really wouldn’t put it past them). Even the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee to vote 11 to 2 against recommending the drug’s approval, but like everything else money trumps science and logic. Are there people who have a legitimate need for painkillers? Of course there are, but that doesn’t mean we can just ignore the obvious problem they have created. These drugs need stricter regulation and stronger abuse deterrents. What is definitely NOT needed is a super strength pill.

  9. dave at 7:07 am

    I believe politicians and the members of NIH consortium are listening. It is up to people in pain to trouble their sleep. With
    creating and sending online petitions, making phone calls to government officials and letter writing campaigns-people in pain can get government to pay attenttion to and address their needs. Currently, government listens to pharmaceutical companies and medical organizations-and frankly, though they claim to promote what is best for people in pain-their “paternalism” is really an occupational strategy in disguise.
    I have seen people in pain organize and successfully lobby agianst step therapy in some states. But until people in pain mobilize, government will continue to serve special interest groups to the detriment of people in pain.

  10. trudy myers at 10:50 am

    Its ridiculous to worry about abuse-their is meth, cocaine and heroin and alcohol-it goes on and on… Chronic pain patients are in HELL everyday. No one can understand the torturous effects unless they have experience it. I even find my young M.D. lacking the ability to truly get it. I read on this site the other day that they want doctors to basically treat chronic pain with no pain meds! If I didn’t have meds I absolutely would end my life. I am not suicidal but a person can only take so much

  11. Lorene Ann Gonzalez at 6:47 pm

    I couldnt of said that any better, Jacob H and Christina. I’m sick to death of the politicians and DEA, agencies, attacking us chronic pain suffers. Everytime a celeb overdoses on pain meds or some teens break into their parents medicine cabinet, they go after us. When will this stop? I’ve been on my pain meds since 2004. I have extreme pain in my spine, due to an automobile accident. I was hit by a drunk driver and as a result my body is a mess. If it were not for my pills, I wouldn’t be able to walk,stand or sit. And may I add I haven’t EVER abused my meds! Leave the pain manegment to the Doctors. And please leave us alone.

  12. Christina at 5:22 pm

    I’m am so tired of these damn politicians sending letters trying to prevent patients from pain relief. Guess what senators if people want to abuse something you will NOT stop them. People abuse alcohol and cigarettes, soda every day you going to go and pull all that off the shelf? Hell no so leave pain patients alone. You have caused enough damage and patients are suffering. That why you doctor is in control of your care and they look for sign of abuse. Stop PUNISHING pain patients!!!!

  13. Jacob Hayden at 4:45 pm

    How much are they going to cost and how should be prescribed 2 or 3 a day so will it be 90 pill prescriptions or 60 what about middle of night pain when you wake up in so much pain your in tears im very interested and will be taking to my doctor about I have been suffering with severe chronic pain since March 12, 2003 I was in an automobile accident a 86 year old man that was I dont know how to spell it but senial and had no drivers license and stole his wife’s car came around a curve and hit my car head on I have major injuries down my spine from C1 down and along with that also comes nerve damage where I lose control of limbs and completely waist down to where I cant walk at times and the list goes on and I think a medicine that you dont have to take as often but works better and longer is a major plus it will save on stomach problems and other internal organs from being damaged and I know all that deal with pain like I do will feel the same way