ZOHYDRO, So HYDRO, No Hydro; What do you think?

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I almost drove my car into a ditch yesterday as even my beloved National Public Radio (NPR) can’t seem to get the Zohydro story right. The recently approved long acting hydrocodone product has not even hit the streets yet but the misinformation, conspiracy theories and media warnings (“be afraid, be very afraid”) abound. NPR’s panel continued to give a voice to the anti-opioid fringe; the ones that never seem to let facts confuse them.  Intellectual dishonesty rules the day. If you ever happen to be listening to someone from the far anti-opioid right bemoaning the overuse of opioids and they happen to spout out that the US uses 99% of the world’s hydrocodone without qualifying that we are one of the only countries that has it, then that should be your warning to take everything else they say with a grain of salt; that is the MALEATE version of prochlorperazine. You know they are trying to scare and overstate and mislead.

But in the end, the reasonable pain doc ended up providing a bit of disappointment when rushing toward the close of the show. While throughout the show he was on message, opioids have risks and benefits; we prescribe them trying to balance these based on risk stratification; we try to use tools and safeguards that are now available to us to monitor adherence and detect problems early like urine drug testing and prescription monitoring programs; we try to use a multi-pronged approach of which opioids are only one piece. All of his points were well-taken, perfectly reasonable and on point. All this while the anti-opioid fringe speaker continued over-stating risks, generalizing about how opioids are highly addictive to everyone and don’t work for anyone.

Whether or not anyone agrees that Zohydro should have been approved at all, or should have been approved as is (without abuse deterrent features) it was approved based on clinical trials data and a perceived need for an extended release hydrocodone product for people with pain. Conspiracy theories were plentiful intimating that the approval came in a smoke filled room between company executives and FDA personnel with questionable motives. PLEASE. The drug has been in development for years, the requisite trials were carried out and the company agreed to unprecedented post marketing surveillance and efforts to ensure safe use. In fact, the absence of acetaminophen alone is a beneficial step in the right direction for certain patients with hepatic issues or those receiving hepatotoxic drugs.

And then the clincher – a man calls in and states that we don’t need such highly addictive drugs when we have safe, proven efficacy in the form of medical marijuana.  And the host asks the pain doctor if he agrees and he says somewhat tentatively that it does indeed have proven efficacy. Now, no one disputes that there is anecdotal and small “n” trial support for some medical uses of cannabis and some analogue cannabinoid drugs have shown promise in some neuropathic pain states in better trials. But to even remotely intimate that marijuana has been the subject of any trials with the size, scope and sophistication of even one of the pivotal trials conducted leading to the approval of Zohydro or any other FDA approved drug in the last decade, is to suggest that someone is smoking cannabis and not necessarily for medical purposes.

Disappointing to be sure; the medical marijuana lobby is making the same mistake that the opioid movement made, which is to argue for legalization or broader use by trivializing risk. Claiming the drug is safe across the board(er). No drug is. Every drug has risks and benefits. Vulnerable people encountering any drug at a vulnerable time, can have a bad outcome, and if we legalize cannabis, it should be because the majority in our democracy wants it to be legal, not because it is completely safe or effective for everyone. Just like people with pain sometimes have problems with loss of control of opioids because they have an exposure to a drug with abuse potential at a vulnerable time (stressed, hurting, isolated) which if combined with personal vulnerabilities (genetic, psychiatric, spiritual) can lead to problems, the same might be expected for a cannabis exposure for pain, especially when combined with other sedative-hypnotic drugs. The likelihood of this occurring to an individual should be calculated thus leading the prescriber to a weighing out of risks and benefits before cannabis would be used in that person, at that time, for their pain. A professional would need to be ready to intervene if disaster strikes, with addiction medicine expertise, time and tools to help. Oh and some reimbursement for their time doing so.

Alas all this talk about whether a given drug or group of drugs is safe or not and distracting everyone from fixing the problems of our healthcare system in the management of pain and addiction. And while we  have been busy fiddling while Rome burns, CMS has been in the process of enacting a new local coverage determination (LCD) on drugs of abuse testing that threatens to castrate one of the most effective tools we have in the fight against drug abuse in and outside of the pain management setting. They are threatening to put all of their stock in a 35 cent outdated cup technology while employing it in a fashion that harkens back to the early days of urine drug testing as a forensic and vocational, not clinical, tool. Rather than fighting about whether the drugs are the problem, all of us should be expressing our outrage toward CMS and protesting their taking away of our discretion to use a tool that we value in ways that help our patients.

Another blog slamming a recent CNN Zohydro report is on the way.  Whether or not extended release hydrocodone provides a useful therapeutic option is a very different question than whether or not is should be in an abuse deterrent formulation.  While the media has successfully intertwined these issues, I will help to clarify in the next post.

And, as always, your comments are encouraged and welcome!

34 thoughts on “ZOHYDRO, So HYDRO, No Hydro; What do you think?

  1. It seems like the public has more concern for the addicts than the people in chronic pain. I would not be able to function daily without these medications. I’ve just been prescribed Zohydro after taking Norco. I hope it works for me. It would be great just to take 2 pills and have relief around the clock.

  2. Conflict of interest? Senator Joe Manchin (WV) is leading the terror attack against Zohydro. The link between Mylan pharmaceuticals, Manchin’s daughter Heather Bresch (who happens to be CEO) and direct competitor to Zogenix’s Zohydro, smells of impropriety. Manchin pretends to care for the people of WV. Mylan produces more than one opiate painkiller, Hydrocodone w/apap and extended release Morphine pills, both devoid of abuse deterrent technology.

  3. Does anyone know of a fellowship trained pain specialist who thinks Zohydro ER should be banned?

    When you find this doctor, please ask if he or she prescribes Avinza (morphine ER) or thinks Avinza should be banned as well. Avinza is essentially a morphine version of Zohydro ER (i.e. they both use the same delivery system – SODAS). Pain sufferers have safely and successfully been treated with Avinza for going on 10 years now. Hydrocodone is certainly not more addictive than morphine. Then why should Zohydro ER be judged differently than Avinza?

    There is no doubt that money talks in government, and that panels of “experts” and bureaucrats don’t always get it right. But I think if we all spent as much time worrying about prevention and treatment of addiction as we are now spending agonizing over this new drug – that will probably prevent deaths from liver failure (i.e. acetaminophen toxicity is the #1 cause of liver failure in the US), we’d be better off.

    1. i guided both of my boys into law rather than medicine. I explained to them that when doctors write the laws for lawyers, the legal profession would be incensed. this is what happens when lawyers write laws for doctors..

      dr. david tarr.

  4. In an attempt to promote accuracy, you should probably correct the post to reflect the fact that urine testing cannot be used to monitor adherence.

  5. It doesn’t take a great deal of research to conclude that there is a huge problem with abuse of prescribed medications in the US. Will it spread to the UK? I don’t think so because the way that the NHS works makes it pretty difficult, with most GPs and Pain Clinicians having a much closer relationship with their patients, with most patients being static and with a strong dispensing system, we are somewhat armoured. Sure, there have been exceptions, but, for the most part, the figures on abuse of prescribed medications are much lower.

    On the other side of the equation, I have been on opiate painkillers for over 14 years and, whilst my body is reliant upon them, I have never got any sort of high, no pleasurable sensations, nothing at all, apart from reducing my pain levels, so I can hardly be addicted. Having been through withdrawal once before I have no ambition to doing it again, but, I don’t fear it. If I ran out I would not go desperately searching for a further supply from some shady guy on a street corner. I might panic a little, but with a shrug of the shoulders, I would simply hunker down in my room, take whats coming and kick myself for being so stupid as to miss reordering.

    Most honest chronic pain sufferers in the US probably feel the same as I do, wonder why the hell they are being labelled as addicts and feel insulted that they are treated like a child by having to sign up to some contract or other promising to be good kids with their meds. Certainly we have to be responsible about where we keep our prescription medications as well as having some sort of system that will alert us if a dose or two go astray. Our medical handlers have to be honest with us too, they have to brief us fully on the downsides of these formulations when they first prescribe them. They have to make us aware that, for many of us, complete relief of pain and other symptoms is not possible (especially for those of us with a neurological condition), yet. As patients we have to learn how to deal with any balance of pain left over, we also have to acknowledge that it is not a good idea to go seeking a pill to deal with the side effects of a pill, that way is an ever decreasing circle of hell.

    I understand there are great differences between your system and ours but pain is the same the world over. Perhaps with a similar prescription system together with a change of patient expectation towards the reality of just what can be done to relieve pain and what cannot, control of the abuse problem can be achieved.

      1. Here is my side of the pond, why is it when a doctor is so afraid of losing anything, its like hell with the patient. You are now on nothing. I been on a little of everything from him for 15 plus years, never failed a drug test even by blood. Now I am suffering because he got scared! HOW ABOUT ME! I am scared as I write this because he knew I was going out of town and wrote me tramdol! Now I am stuck, I called him and he said oh well I can’t call you in anything. That is why SOME people go to the streets. I am not, but I now understand! Why???

    1. This message is in response to Mike Feehan’s post on March 2nd 2014. I totally agree with you that people(who probably have no experience with chronic pain) are making a Huge deal over a medication that’s not really that strong to begin with. People thing that this drug is going to have the same problem that OxyContin had before they changed the time-release method. By the way, did you notice that Purdue pharmaceuticals changed their formula volunteerly just as their pattent was up, & any pharm. company could have made a generic version, costing Purdue big bucks. Purdue(the makers of OxyContin) told the FDA, & DEA that they now realize their pills were unsafe, and easy to abuse. The feds bought their story, & Purdue re-formulated the Oxy to make it harder to abuse. Like it really took Purdue 5yrs to realize that people were crushing, & snorting their OC’s. By waiting until the 5yrs(length of their pattent) was almost up before changing their formula, they essentially created a new medicine, and extending their pattent by another 5 years. So OxyContin still has a monopoly on the most popular, & addictive pain pill on the market(even though the “New OP’s” aren’t nearly as good as the “Original OC’s”). I guess the FDA learned their lesson though, because Opana(oxymorphone) tried the same thing. Regular users realized that you can chew the pill, instead of swallowing it whole, & they would get the full dose at once, instead of over a 12-hour period. When it was time for their pattent to run out, they announced that they were going to make the pills with a harder(plastic like) coating. The FDA, & DEA applauded them for doing their part in curbing addiction, but they said that that actual medication is the same, so they didn’t get an extention on their pattent. The makers of Opana did change their coating to a harder substance, but Activas, & I think at least one other company is currently making generics, & they’re using a regular soft coating that people can chew with no problem. I actually know a pharmacist, and she tells me that people ask if she has the Activas Brand, & if they bring in a doctor’s prescription & she doesn’t have it, or have enough in stock, then they beg her to order the Activas brand, or the other generic brand with a thin coating. OK, now that I’ve gotten that out of the way, I’d like to go back and touch on something that Mike said. Why are people more concerned with addicts, or the fear that someone will become an addict, than the people who live in chronic pain on a daily basis. It’s been 7.5 years since my accident, & after a two week stay in the ICU, & another 6 weeks in the hospital, I’ve been in severe pain, every day since then. The two months that I was recovering in a hospital room in Palm Beach, FL I was given 8mg Dilaudid IV shots thru my central line every 6 hours(32mg. IV Dilaudid(hospital herein)) a day), plus 10mg of oxycodone between the Dilaudid shots. So that’s another 40mg of oxycodone a day. Also, let me tell you, if you’ve ever taken an 8mg Dilaudid pill; it’s totally different than taking an 8mg IV thru your central line. I mean that medicine hits you instantly. I’ve never been a big fan of needles, & meeting strange guys on the street corner, but the first few times I was given my IV, I could see how people could get addicted to that disgusting habit. I asked a pain management doctor that I was seeing when I was finally discharged from the hospital, who had me on 80mg Methadone/day(yes, that’s when they still made the 40mg wafers. The orange kind were my favorite, among with (4) 8mg Dilaudid tabs/day, to wean me off opiates supposedly. Anyways, I asked the doc why it is that when I’m given 8mg hydromorphone(Dilaudid) in IV form, it knocks me on my ass, but when I take an 8mg Dilaudid tablet, it feels like nothing, like a Flintstone’s Vitamin. He told me that it had to do with the route of administration. He said that i’d have to take about (10) of the 8mg tablets, to get the same effect as (1) 8mg IV Dilaudid shot. That’s 10X as much in pill form. I moved from Florida to the Boston area about 3 years ago, & when I left FLORIDA I was taking (3)OxyContin 80mg./day, plus (3) Roxicodone(oxycodone) 30mg/day for Breakthrough Pain, & every month when I went to see my doctor, he’d ask what my pain level was, & I said 7 or 8, because that’s what I thought a 7 felt like. My current pain doc has been cutting me way down, & I’m currently only taking 15mg MS-Contin, & 5mg oxycodone. Now I know what a 7 really feels like. I’d love to find a doctor who will prescribe ZoHydro, because that with a short acting med(like oxycodone) should do the trick.

  6. Medical marijuana works well for many and opioids work well for many. These work in different ways and aren’t mutually exclusive. Medical marijuana is insufficient for many types of pain. Bottom line: people should be free to take what works for THEM. We need Zohydro because some opioids work better than others for some people and that pattern is not the same for everyone. I am really disappointed in Public Citizen for repeating PROP’s talking points one by one without doing any checking. Public Citizen has done a lot of good in other campaigns, but they are out of their league in attempting to understand this issue. Perhaps we can start a writing campaign to Public Citizen? They have a lot of resources and it is a shame that they have been co-opted by PROP. If they apologize and retract, that will be huge! In what other branch of medicine is concern over the “rights” of deliberate abusers elevated over the rights of actual patients taking a medication as prescribed? Oh, that is right— NONE but pain management! For shame!

    1. I’m not an expert, but I was an LPN, I did study pharmacology, and had to know what I was giving. Now, I’m on the other side. Marijuana and opiates are two different formulas. Just as say morphine and oxycodone. What works for one, may not work for another. Also, imo used for different things. If it helps someone when nothing else will, what should be the problem. As for “keeping opiates under lock and key”. Would anyone responsible leave any medicines, alcohol, cigarettes, guns etc where others can get to them, if they so desire? Aspirin can be deadly if taken in a large enough quantity, think orange flavored aspirin for children…

  7. One of the best surgeons at the Medical Center here in Houston told me after looking at my MRI if you keep seeking out surgery one day a doctor will cut on your neck and you will regret it the rest of your life. So that ended my quest for surgery. I had epidural injections that did me no good then this doctor did Botox injections to my cervical spine. When I woke up in recovery it felt like bee’s had stung me all over my neck and my tongue began to swell and my throat closed. The nurse had to shove a tube down my throat so I could breath. They administered something to reverse the Botox. That would be the end of being prodded and injected for myself.

    I found a great Pain Specialist that started me out on a time released pain medication and titrated me up within a 6 month period. I could not believe the pain relief I received. For 10 years I suffered and finally I found pain relief and was able to return to work for 6 more years. Then this disc problem I have in my cervical spine spread down my entire spine. I could no longer work and was 48 years old. So I began to do volunteer work for my Pain Specialist and I advocated for those in chronic pain. I also write for those in so much chronic pain they cant write for themselves, I’m now 58.

    We live in a free Country with freedom of speech, freedom of religion, freedom from want and freedom from fear. Everyone has the right to a standard of living adequate for the health and well-being of themself and their family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond ones control .But it seems were slowly losing sight of the freedom from being as pain free as possible. How did it come to this, why does everyone fear pain, yet we cant seem to come to terms with medications to keep those in severe chronic pain as pain free as possible. Do any of you have the answer to this.

    1. i have been dealing with pain since I was hurt in army at 19 in 1990 I didn’t have serious problems with it until2001-2002 saw doctors had surgery had many injections an have had nerves burned probably a dozen times had a good interventional pm doctor that after seeing for years and knowing of all other ortho/ neurosurgeon s didn’t advise any other surgery( risky with no probable) reward anyway was referred to other intractable specialist. So I had new dr. All was good until dr lost license after more years for them not liking her ” non judicious ” prescribing practices since then new dr who doesn’t even know me after seeing him for years decided he is getting out of chronic pm and only interested in new accidents and interventional pm. Worse every month for 5 months he has reduced my dose and reduced times per day before he even in formed me of his plans citing he was concerned with pressures from medical board and dea . I need my relief I lose work when I can’t function I am really at my ends I have lost many things because of my dis abilities marriage/ family life , good consistent work, other health issues because of inability to exercise , overweight, insomnia from pain, social life ,anyway I am searching for a new dr that willing to treat with enough medicine and courage to let me function at a high level again like I did when I was seeing the dr that list her license believe it or not when medicated enough I was a star employee at local shipyard ran crews was in charge of dimensional accuracy of 20 to 50 million dollars blocks of ship assemblies was an inspector had to sign off with Northrop Grumman and U.S. Navy upon completion of blocks during this I used cranes run welders and torches fork lifts saws and everything that the labels wen you to know how you respond anyway now my pain an inability to get relief also in spite of me selling most of my valued property just to pay for medical insurance 660 per month I have not been able to afford the rftc nerve burning as often I need it about 3-4 times per year or the spinal cord stimulator that has been suggested since I was 35 I am now 44

  8. Chronic pain is a 24/7 disease… In my professional opinion.. treating chronic pain with anything other than a long acting med – dosed every 8 hrs.. with a immediate release to handle break thru pain.. Is nothing short of pt abuse and perhaps a form of torture. IMO.. we have a epidemic of chronic pain because we are so reluctant to aggressively treat acute pain.. the pain becomes engrained in a nerve pathway and thus we have a chronic pain pt.. and unable to reverse the nerve pathway back to its “normal state”.

  9. Ehlers Dankos, Fibromyalgia, and Arnold Chiari Syn. have made pain my constant companion for the past twenty years. Like millions of others, there is little that medical science has to offer us. We have been examined, prodded, scanned, irradiated, injected, and scarred from surgeries. Seen the best (and the worst) that our esteemed medical schools can produce.We have been disbelieved, patronized, and sometimes exploited. Some of the medical communities’ efforts even help, for awhile. Some don’t, some make you worse. Through all of this, we still have lives to live, such as they are. While I strongly believe in incorporating complimentary modalities such as yoga, nutrition, massage & hydrotherapy into any pain management program, for many of us, they cannot give us adequate relief. We deserve to have the best quality of life that is possible – like everyone else. We also deserve our dignity, and not disbelieved, discriminated against, and treated like junkies for needing a medication that many times, can keep us functional for many more years than we would otherwise be. Active, productive, humans with so much to contribute, either because or in spite of our difficulties. We have enough challenges- just please don’t add to them . We are a “captive audience ” to the politics of medicine, whose philosophy changes regularly. Will this particular “opioid scare” leave empathy dead on arrival? I hope not…for all of us.

  10. Zohydro will be great for those new to chronic pain and for those that have never taken a time released pain medication. I was in the clinical trial and believe me Zohydro is not at all what people think it will be ,it doesn’t even come close. All this misinformation, conspiracy theories and media warnings (“be afraid, be very afraid”) what is there to be afraid of. If you look to abuse any pain medication you should be very afraid or stupid. We must have these Anti-Opioid mongrels to spout off and cause unnecessary fear. There’s nothing to fear but fear itself.

    If you try to switch from Methadone or OxyContin to Zohydro your wasting your time .Your going backwards in the relief of your chronic pain . You might think Zohydro will be this next new terrific time released pain medication but if you have any tolerance at all to opioids stay on your original plan your doctor has you on. Keep it simple and don’t raise any red flags. Anti-Opioid mongrels do enough damage just acting like they know it all, when in fact they know very little.

    1. Hey Mark!

      My question in regards to your comments on the zohydro clinical trials. I will “on occasions” have “bad” chronic pain days. Cervic neck surgery and fibromyalgia. I will take norco 5mg up to 3x a day. That is a strong dose for me. My concern with zohydro 10mg is – will it be too strong for me. I don’t like to feel stoned. Just pain controlled. I am definitely a light weight. What are your thoughts in dosage of zohydro 10mg and how it will feel?

  11. Thank you, Dr. Fudin. With all the overuse of acetaminophen these days, I would think a Hydrocodone formulation without it could be of serious benefit to people who use it (as prescribed) for pain.

    In terms of the abuse deterrent formulation….I have a personal issue with this. Years ago, when I was first prescribed OxyContin for intractable pain, my life changed for the better. I had no side effects, no issues, and a dramatic reduction in daily pain. When the “new & improved” version (abuse deterrent version) came out, I didn’t know the pills were any different at first. They were the same color, shape, size, and I had never looked at the letters printed on the medication anyway… Within DAYS, something changed, for the worse. I won’t go into all the details, but basically, my pain was uncontrolled, I had terrible anxiety (something I wasn’t generally experienced with), HORRIBLE stomach pains, headaches, painful bowels, nausea, and a whole host of other issues. I thought I had contracted a strange stomach virus, or that I had developed a new debilitating symptom of my Ehlers-danlos Syndrome. I was devastated! Thankfully, my doctor called my pharmacist, and discovered that the change coincided with my receiving the new, “abuse proof” formulation.

    This may seem like a small price to pay for the benefit of the general population, but what I learned was that I wasn’t the ONLY one this happened to. Many people experienced terrible side effects of the new formulation. Some of us couldn’t digest the “plastic” glue-like material that was in the “improved” version & it made us very sick. All I know, is that this change, and subsequent discontinuation of OxyContin drastically effected my quality if life, my daily pain, etc…

    What I have issue with, is the fact that these changes are made to benefit the very people who SHOULDN’T be taking the medication to begin with! The people who were abusing it, either found away around it, or switched to different drugs. Medication changes aren’t so easy for people with serious pain who have found (at last) something that lessons the torture of living with disabling persistent & severe pain every day. This, i know….Heroin overdoses have escalated despite these reformulations, and perhaps in some cases because of them.

    I am terrified and saddened about the way all opioids are being vilified in the media these days. For some of us who have serious pain conditions for which there is no cure….only the management of symptoms, these medications can make the difference between wanted to die, and having the will to live, despite the pain they cause. So, for all the conspiracy theorists out there, just be grateful you are not someone who requires opioid medication just to survive horrendous pain every day. You would feel pretty lousy about the fact that people think you don’t matter, you don’t deserve relief from torture, and that the people who buy illegal drugs on the street and overdose on them, have more worth than you do. THAT is a pretty hard pill to swallow…

  12. Anything in the physician’s armamentarium–that has met standards–to dial back the epidemic of pain should be appropriately used with the right patients. Those who extend themselves to treat us, against some growingly hefty odds, and those of us who can benefit by this medicine, once approved, should be left alone, with the exception of follow on research to see how this medicine is doing.

    Much of the opposition to this new medicine has a history that reaches back into the war on drugs, not medicine, drugs. Anything that has the potential for abuse, let me repeat, anything that has the potential for abuse is singled out by the proponents of the war on drugs, as a target.

    This possibly break-through medicine for those of us in harrowing pain is being subjected to the strictures of the ever present, though scientifically rejected, war on drugs.

    Those of us who could benefit by this new medicine are already being held under the glow of interrogation lights as possible criminals. We will take these powerful medicines and divert them into illegal channels so we can make a profit.

    The simple idiocy of this idea needs to be presented as the alternative to those who need pain relief in the worst way. I hate to burst a bubble, but I wouldn’t sell this new, possibly life saving meds for all the money awash in the illegal drug markets. Those of us in harrowing pain aren’t interested in diverting our meds, we want relief, however thin or fleeting that relief may be.

    Will this new medicine enter illegal markets. Most likely, yes. Where there is demand, there will be supply.

    But is law enforcement the avenue of response to this? Stated simply, no.

    We desperately need education and drug treatment on demand.

    Ask yourself this: Is the capture of the leader of the Sinolola Cartel going to make any difference in the availability and sale of illegal drugs? The answer in most news reports is simply no.

    I bring this up not as an argument to leave this new medicine alone, but to highlight that the war on drugs has been a colossal failure.

    We don’t need enforcement, we need care, on demand care for those who’ve been addicted.

    Until we do this, the regulatory pressure on new, possibly effective medicines for the control of pain, will meet the same fate as Zohydro: demonized before it has a chance to be effective.

  13. Anything in the physician’s armamentarium–that has met standards–to dial back the epidemic of pain should be appropriately used with the right patients. All other propaganda, whatever its official origin, should be viewed as just that, propaganda.

  14. I, too, heard radio news reports on Zohydro® and they were quite biased in their objections to release of the drug this March; very little fair balance. Then again, I never thought too highly of hydrocodone, since many research models have shown it to be no more effective than high-dose ibuprofen; at least for acute pain. And, whenever I’ve personally been prescribed hydrocodone+APAP I never experienced any sort of pleasurable “buzz” that abusers claim to feel — maybe, it’s a metabolic thing.

    Still, abuse-deterrent formulations of opioid analgesics seem to be state-of-the-art these days, and one must wonder why a new extended-release or long-acting opioid would be approved without it. Or, why a manufacturer would even want to newly release such a product that may encounter significant misuse and abuse, along with subsequent government sanctions and the ongoing wrath of the anti-opioid crowd. I know, I know… it’s all about the money, but isn’t there still such a thing as common sense? Maybe, not.

    1. In the FDAs response to this issue: “To date, the FDA has only approved one medication with such features, a tamper-resistant version of OxyContin in 2010.” Others contain acetaminophen or ibuprofen which can be toxic to the liver or have other adverse reactions. The FDA stated that tamper resistant “technology is poor” and can have adverse effects in and of itself. There is no good answer here but to quote another poster “In what other branch of medicine is concern over the “rights” of deliberate abusers elevated over the rights of actual patients”

  15. Let doctors and patients hash out things like what medications to take. Don’t like the med? Don’t take it. Pain patients have a hard enough time getting relief in the US; the last thing we need is a bunch of prohibitionists and busybodies meddling in the doctor/patient relationship.

  16. Zohydro will be the new pre-abuse-deterrent OxyContin. I’m guessing that it will fetch $2/mg on the street, where most of it will end up. Check out my editorial in last month’s Journal of Pain Research on why ALL time-released opioids should be in abuse-deterrent form.

    1. You must not have endured chronic pain in your lifetime. Our government is so corrupt. I truly believe this. Also, take into consideration that most all chronic pain patients are held responsible and sign contracts with their pain management doctors. We are responsible for our own actions and practice that responsibility regularly while we are charged out the wazoo for simple urine screens for urine testing and treated like drug addicts just seeking simple relief from very real and intense pain. We, as chronic pain patients have had enough and are now standing together. We have rights too. I live in the “famous state of Texas” lol where doctors are now afraid to prescribe anything to anyone who is truly in pain. I am a “middle of the road” person when it comes to politics and that’s where most people stand. I am not from Texas and have lived in many states. This state produced the now famous Ted Cruz who effectively shut down our government. Now Republicans are distancing themselves from him. HA! No, doctors here would rather proceed with mostly experimental “procedures” that don’t work, are very expensive, cause more pain in most instances are uninsured in many cases and just add an excess burden on the medicare system. I say “Get Over It”!!

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