FDA Pushes to Increase the Development of Abuse-Deterrent Opioids

FDA Pushes to Increase the Development of Abuse-Deterrent Opioids

The US Food and Drug Administration (FDA) is working hard to make sure that generic versions of abuse-deterrent opioids are just as deterrent as the brand named opioids.

“For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care,” said FDA Commissioner Robert Califf, M.D.

“We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy,” he added.

FDA is encouraging industry to develop pain medicines – opioids in particular –that are far more difficult to abuse.  Abuse-deterrent characteristics make certain types of abuse, like as crushing a tablet in order to snort the drugs, or dissolving a capsule in order to inject it, more difficult.

The draft guidance issued in March (“General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products”) includes recommendations about the studies that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the brand name product, with respect to all potential routes of abuse.

The guidance for generic abuse-deterrent opioids follows the agency’s final guidance for brand name opioids, “Abuse-Deterrent Opioids – Evaluation and Labeling,” which was issued April, 2015.

The FDA will hold a public meeting later this year to discuss the draft guidance on generic abuse-deterrent formulation (ADF) products and a broad range of issues related to the use of abuse-deterrent technology as one tool to reduce prescription opioid abuse.

“Collaboration is critical in fostering innovation in the field of abuse deterrence,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “It is essential that a generic product is no less abuse-deterrent than the brand name product. We look forward to actively engaging in discussions to help inform our thinking about the evaluation of abuse-deterrent technologies.”

The FDA encourages feedback from all stakeholders during the 60-day comment period on this draft guidance.

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Authored by: Staff

There are 23 comments for this article
  1. Cyndi at 4:39 am

    Gina there are alternatives out there if you look and they are working well. I don’t see doctors for pain anymore, I buy herbal remedies online and they are mailed to me.

    Do what tens of thousands are doing and turn your back on the system, get relief and get your life back.

  2. Gina at 11:13 pm

    I have had RSD 20 years. My yearly pain management appointment was not with s doctor but a surprise pharmacist. At age 55 with six years of passed drugs screens I was asked if I used meth, cocaine, marijuana and talked over, told I’d become “pain numb” could hit my toe with a hammer and not feel it. That my oxycodone needed to be cut in half. Demonstrated, the use of a naltexzone injection, when I said I would never abuse or take too much of my pain medication and overdose, I was told, whether I disagreed or not I was being sent the cartridge. Next appointment after having my medications cut in half is with a multidisciplinary team. Cause for this abuse by a pharmacist, was that I didn’t try other pain alternatives. The chronic pain from my illness know longer matters as a veteran being treated by the V A in this manner and reporting the incident has been ignored. I pray nightly that the quality of life I’m losing be restored at the multidisciplinary meeting or else I cannot see living with this out of control pain or another way outside this treatment, as they have labeled me “opioid dependent” I’m as dependent as an insulin dependent diabetic, yet the stigma will cause no other pain management to believe my story. The life ahead for chronic pain sufferers is going to be one where we are so filled with pain, hurt that no one cares, other than to swear your illnesses are secondary to drug seeking, that the suicides will be from pain. The naltrezone cartridge will not be needed and yes the b***head sent it, in spite of my demand that he not. Hurting and fed up that as a disabled nurse I’m faced with a future I’m scared think and praying someone realize this is not patient care.

  3. Jeanie at 5:39 pm

    Jean, Oxycontin OC had a small amount of the drug in the outer coating to provide some pain relief immediately…Not anymore with the abuse-deterrent alternative…so it takes much longer to relieve pain. Patients are told not to be alarmed if they see undigested pieces of the pill in their stool. Many patients experienced withdrawal symptoms when they were switched from the original Oxycontin OC formula to the abuse-deterrent OP formula so, how much of the pain reliever is still encased in those undigested chunks found in patient’s stools. The FDA does not care about pain sufferers pain levels or side effects with the abuse-deterrent opioids. So, I’m sure testing is not done concerning this. I’ve never read about any testing being done in trials with pain patients. The only thing the FDA cares about is that the opioids are harder for drug addicts to abuse…that IS their priority; in fact it’s their ONLY concern…period..

  4. Jean Price at 8:02 pm

    Does anyone know if they were required to do efficacy and bioavailability studies on these new configurations. One proves and measures effectiveness and the other proves and measures the drug getting into the blood stream. My guess is they didn’t. If these are considered ” new” generics, I’d think they have to study these parameters to be in line with FDA regulatory practices. But then, why bother…they’re just to treat pain! Not a big deal, right? WRONG!!

  5. Jeanie at 9:25 am

    Joan, The new generic versions of Oxycontin in the U.S and recently approved by the FDA, are generic Authorized versions of the abuse-deterrent Oxycontin, which means that they are exact replicas with all the polymers and fillers that the brand name contains. The FDA is refusing to authorized new opioids that do not contain the polymers and fillers. The FDA stopped authorizing generics without those particular abuse deterrent fillers when Purdue Pharma’s patent was made available to other companies producing generic versions. The FDA wants ALL new generics to contain the polymers and fillers that Purdue originally patented but is now available to other companies. If and when the FDA approves any new opioids that are not exact replicas, they will still contain the polymers and other abuse-deterrent properties but some of the other inactive ingredients may be different. For many pain patients, the original Oxycontin (OC) formula was a lifesaver in managing their pain, with few side effects. When the Oxycontin (OP) abuse-deterrednt version was introduced as the only option for pain patients who had been on Oxycontin, the majority felt that their pain was no longer adequately controlled and, they began experiencing horrific side effects that they did not have with the original Oxycontin formula. The FDA wants to see ALL opioids with the abuse-deterrent polymers and fillers that some German company patented for Purdue and they are reticent to approve any new generic opioids that do not contain them. Polymers are not a good thing you know. It’s the same compound used in Sculpey (oven bake clay). It prevents the opioid from doing its job of relieving pain and it causes undigestable blockages in the digestive tract. They might as well tell patients to eat a ball of Sculpey clay after each opioid administration.

  6. JOAN at 8:40 pm

    The generic and anti-abuse versions of these medications DO NOT CONTAIN the same polymers, fillers and coatings as the BRAND drugs!! Due to this fact, many of us cannot take these generic substitutes due to the Adverse reactions (that supposedly don’t exist) or they just DO NOT WORK!!

  7. Jeanie at 11:17 am

    Benzhydrocodone/acetaminopen is supposed to be a new abuse-deterrent Hydrocodone (Vicodin) formulation with benzoic acid. But it looks like the FDA does not feel that it is abuse-deterrent enough without the polymer fillers that make the opioids not work as well and cause a whole lot of untoward, nasty effects. But I guarantee, the FDA will give it full approval if the abuse-deterrent renders the opioid effect useless & makes the patients frightfully ill. Those are the new criteria for opioid approval now…and the new definition of abuse-deterrent!

  8. BL at 1:45 pm

    Does anyone know anything about benzhydrocodone/acetaminophen (6.67 mg/325 mg), or KP201 (Apadaz),? It was voted on at the FDA REMS Advisory Committee meeting Thursday.

  9. Jeanie at 9:06 am

    Why does the FDA not understand that severe pain sufferers do not need the meds to be abuse deterrent? I am a nurse who works on both sides of the fence. I work with severe pain sufferers. Their complaint is that the new abuse deterrent opioids do not work nearly as well as the original formulations and, more often make them sick. So, their quality of life as again been diiminished because of drug addicts and a panel who makes decisions. And, on the other side of the fence, I work with drug addicts. All of the addicts who at one time used Oxycontin, are now using Heroin. So, who is benefitting from this? From what I see and live everyday….NO ONE! Give pain sufferers what they need, a pain med that works without all those fillers that cause side effects. And give drug addicts the treatment they need, instead of concentrating on the drugs they abuse because it isn’t helping.

  10. BL at 7:40 pm

    Has anyone read the one comment made at the Federal Register website ?

  11. Cynthia Martinek Phillips at 7:16 am

    I’m a chronic pain sufferer and was caught up in all this for so many years. The real solution is to actually treat the small minority who have addiction issues (caused by doctors who cut people off without warning which should be illegal). If you make it harder to abuse pills they just turn to heroin or something similar so you aren’t fixing anything. Let the rest of us carry on with whatever works best. Most pain patients have been dealing with it for many years and we know what works.

    And how about real treatment instead of trading one addiction for another? Methadone and suboxone can be just as dangerous as what they replaced. Kratom on the other hand treats addiction successfully without all the problems associated with the “preferred” drugs.

    I found some herbal remedies that worked better than the narcotics yet don’t get you high or kill you like what is prescribed. No more traveling to the next county to see a pain doctor who doesn’t care about me, treats me bad, forces injections in my spine while I’m awake even though they don’t work. No more driving from pharmacy to pharmacy and lied to about them having my medication. My depression is gone because I’m not dealing with nasty people and I’m not in nearly as much pain.

    Drug companies can’t own the herbals so they don’t want to spend money on research or promote their safer treatment. They should be worried more about us and less about money.

  12. Jean Price at 7:54 pm

    I hope they are not supporting the “abuse deterrent” meds that contain naloxone! That’s not abuse deterrent, it’s adding in another medication I don’t want to take! And I have to believe when you mix a pain medication with a pain med antagonist medication, the pain medication losses some effectiveness at controlling pain. To make them uncrushable and nondissolvable will be difficult, if they are still going to dissolve in people’s stomachs! But maybe they’re really not concerned about that!

  13. Jill at 5:27 am

    Now I feel ridiculous. I do know it’s opioid not opiods. My only excuse is I tend to go on this site when I’m in so much pain I can hardly think. My frustration level is so high I just want to scream, which I’ve done a fair amount of over the years. I was diagnosed with osteoarthritis in my lumbar spine over 30 years ago. Nothing fancy here. Just plain old arthritis. Causing me to suffer moderate to now severe back pain EVERY DAY since. I’m worn out fighting this disease.

  14. Bella at 5:31 pm

    I think this is a joke. I belong to groups who are suffering everyday from pain. Week not crush or sniff or inject opioids. I do see a lot of news on overdoses. But I don’t think it’s linked to people with for if pain. These are people who got their opioids from the street or their parents medicine cabnit,etc.
    And now anyone who has pain or needs opioids to maintain a normal life are being treated like criminals and addicts. ENOUGH IS ENOUGH. DEA knows the difference. If I as a household parent knows the difference, so should they. You are forcing people who have pain to commit suicide. It’s not hard to differate between the addict and non addict who just seeking a normal life and to be a me to function.
    Stop blaming the real pain sufferer’s as the problem to this very sensitive subject.

  15. Jill at 5:02 pm

    This sounds so ridiculous!! Why should chronic pain sufferers have to pay for the expense involved in developing abuse-deterrent (not abuse proof) opiods when abuse is not our problem. Many can’t get the opiods they need to function much less abuse! This will only make the big pharma richer and people in pain suffer more!!

  16. LINDA LENTINE at 3:46 pm

    Heroin users will continue to use and die from heroin overdoses . The problem has never been with Chronic Pain sufferers that take opioids as prescribed. Chronic Pain Sufferers or CPS are the unintended target of all of this mass hysteria . People that overdose on Heroin have not been separated from people overdosing on pain medications in the studies used to pass new “Guidelines ” . Also , for the past 10 years we have had an influx of usage for pain medications due to the fact that soldiers are coming home with serious pain conditions & Baby Boomers are coming of age . Instead of dealing with this in a humane way to treat and help people attempt to maintain some form of a dignified life , the CDC , Dea and others have decided to treat all as repulsive addicts .

  17. John Burke at 8:28 am

    I’m sure that was tested during the process. In addition, there is a brand new oxycodone extended release product that is abuse-deterrent where the capsule can be broken open and the drug sprinkled on food. That may help some of your fears of the digestion issue.

  18. Cathy M at 7:25 am

    A worthy goal, but as with many other “preventative measures” it could harm the responsible med-takers (by making something so expensive, that insurance won’t cover) and still not prevent the abusers from abusing (they have much motivation and time to learn to “break” preventative measures – a lot like hackers). I hope that with the guidelines, they mandate that insurance covers these medications at the same level, ie: same cost, as the current generics (because any new versions of these will no longer be generic, right?)

  19. Deb at 6:54 am

    It is great that they are making the drugs so that they can’t be abused. The problem with it is some peoples bodies don’t process these drugs. I was taking opana er when they changed the formula so that it was abuse-deterrent. I got no relief from the new formula. In fact I got really stupid because it was not working for me and ended up taking enough that if they did kick in I would have overdosed. Of course my doctors office told me it was impossible that the new formula didn’t work for me because all they changed was the abuse-deterrent. If the medical community is aware that sometimes these new formulas just don’t work for some people this is an excellent way to keep the addicts from taking the meds we so desperately need.

  20. Venita at 4:13 am

    Guess what, FDA Commissioner Califf, many of us with chronic pain are not addicts and we don’t crush and sniff or inject opiods. If we are lucky enough not to have been kicked off an appropriate dose of opiods by our PCPs or pain management specialists because of state, FDA, or CDC requirements (or “guidelines” as you hypocrites like to call them), we take them as directed, or even in smaller doses PRN. Sure, we may be dependent on opiods to have some quality of life, but that doesn’t make us “addicts.” We just want to be productive members of society or even have the limited energy to take care of ourselves and our families.

    And it is amusing to me that the CDC’s last action for restrictive “guidelines” only took a few months despite heavy pushback from the chronic pain community, but the “studies” you are now suggesting are going to take most of a year. You are asking, apparently almost demanding, that chronic pain sufferers turn to suicide so that the voices of those in chronic pain are silenced.

  21. John Burke at 3:22 am

    Since I am a strong proponent of abuse-deterrent opiods it would make sense that the generics would have the same requirements.

    However this technology is expensive and generics indicate their profit margin is already low.

  22. Candice Peoples at 3:19 am

    I just wonder,if they are hard to crush,then how hard will they be to digest. I suffer with chronic pain. So this question comes from a strictly informative place