Review of Abuse-Deterrent Opioid Painkillers Open for Public Comment

Review of Abuse-Deterrent Opioid Painkillers Open for Public Comment

The Institute for Clinical and Economic Review (ICER) has published a draft scoping document about abuse-deterrent formulations (ADFs) of opioids and how they may contribute as part of integrative pain management.

ICER’s report will review the “evidence on several new and emerging opioid re-formulations to evaluate how effectively they reduce opioid misuse and its many consequences.”  Analyses will also be performed to provide information on the long-term value of abuse-deterrent opioids for the health system and for society.

The population of focus for the review will include all people who use opioids for therapeutic (as prescribed) and non-therapeutic use (abuse, addiction).  ICER will look at several key subpopulations including the following:

  • Patients with non-cancer chronic pain, stratified by age group where feasible
  • Patients with cancer, with particular attention to cancer patients in palliative care
  • Recreational drug users
  • Persons addicted to opioids

The drugs of focus for the review will include:

Currently FDA Approved Drugs

  • Oxycontin® (oxycodone extended release, Purdue Pharmaceuticals)
  • Hysingla® ER (hydrocodone extended release, Purdue Pharmaceuticals)
  • Morphabond™ (morphine extended release, Inspirion Delivery Technologies)
  • Xtampza™ ER (oxycodone extended release, Collegium Pharmaceutical)
  • Embeda® (morphine + naltrexone extended release, by Pfizer)
  • Troxyca® ER (oxycodone + naltrexone extended release, Pfizer)

Drugs Pending FDA Approval

  • Vantrela™ ER (hydrocodone extended release, Teva Pharmaceuticals)
  • Remoxy™(oxycodone extended release, Pain Therapeutics)
  • Arymo™ ER (morphine extended release, Egalet Corporation)

ICER identified numerous stakeholders for input on its upcoming report, including some familiar organizations engaged in the CDC Guideline for Prescribing Opioids for Chronic Pain, such as:

  • Physicians for Responsible Opioid Prescribing (PROP)
  • US Pain Foundation
  • PAINS – The Pain Action Alliance to Implement a National Strategy

A full list of stakeholder organizations can be found here.

ICER also “welcomes suggestions from the broader community on additional organizations to add to this list. ICER also receives input from independent patients and clinicians, and invites the public to submit recommendations for key stakeholders in these categories.”

The draft scoping document will be open to public comment for three weeks until Wednesday, September 28, 2016, at 5pm ET.  Comments can be submitted by email to publiccomments@icer-review.org.  More information about submitting a public comment, including formatting specifications, is available here.

Following the public comment period, a revised scoping document will be posted on or about October 6, 2016.

According to its website, ICER is a “non-profit organization that evaluates evidence on the value of medical tests, treatments and delivery system innovations and moves that evidence into action to improve the health care system.”

ICER’s website also addresses “myths about ICER” including that it is a front to the insurance industry, ignores patient perspectives, discriminates against those with serious health conditions, restricts access to patients by making them take less effective and older medications first, among others.

You can read ICER’s positions on these topics here.

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Authored by: lynch

There are 15 comments for this article
  1. connie at 4:08 pm

    First let me say that adding lord knows what to make medication long acting doesn’t seem to be the safest thing to do in the long run.
    Recently,due to the CDC GUIDELINES the medications that I have been taking successfully with no change in dosage, were changed. I was on fentanyl 125 mcg and dilaudid 4 mg every 3 hours. Yes it sounds like a lot but my body uses up medication at a fast rate. From this successful treatment I was placed on oxycodone er with dilaudid for breakthrough pain. We started with 10 mg oxy twice a day and am up to 30 and the fentanyl dose is now 25 mcg. The dilaudid is down to 1mg twice a day. Obviously the oxycodone isn’t being effective at these doses and the amount of breakthrough pain is in no way being controlled. All my life I have fought chronic constipation and while fentanyl didn’t make it worse the oxy has made it into a battle that I am losing! So while I was, with the help of the proper medication, keeping my pain level at a consistent and liveable 6/7 it is now a less acceptable 8/9 and my problem with chronic constipation is MUCH worse. I would say that changing my medication has not been successful!
    I am NOT an addict, I am a person who lives with a lot of pain 24 hours a day. I have had periods of pain for a lot of my life and when finally the source of that pain was found and fixed the painkillers were instantly gone too. This pain I now live with is not going to go away. Am I and thousands of others like me to be sentenced to a miserable existence because of a few who misuse their medication or worse yet people who are addicted to street drugs like heroin or methamphetamines ? If I were using heroin I could go to a clinic and be given methadone or some other drugs to make that addiction more tolerable but as a pain patient I am forced to suffer. This isn’t right! I am one of the lucky ones who still gets some pain control and my heart breaks for those who aren’t so lucky! The powers that be need to understand that we are human beings and each of us respond differently to medications. Quit putting us all in one box, especially when that box includes actual ADDICTS!

  2. HJ at 8:16 am

    Marybeth,
    First of all, I’d like to say that I’m so sorry to hear about your son. I am sorry you deal with such heartbreak. I feel very sad to read what happened.
    I read what Jean Price wrote and will say that I agree with her and I hope you’ll have an ear for those of us who want to see physicians who prescribe responsibly, who don’t want to be harmed, who want to use medication responsibly… Personally, I WANT my doctor to educate me about these medications. And sadly, doctors are rushed on to the next appointment.
    I don’t know the specifics of your son’s situation so please forgive me if what I’m saying isn’t in line with what you experienced. I just want you to know that I want things to get better, too.
    But “getting better” doesn’t mean a ban on all opiods for everyone. There aren’t alternatives out there. Specifically, there aren’t legal, non-addictive alternatives. And pain is real. Sadly, people commit suicide because they can’t deal with what the pain has taken away from them in their lives (their employment, their financial security, their ability to spend time with their families… things that give their lives personal meaning). An all-out ban will harm a lot of people who aren’t addicts.
    Personally, without medication to manage my pain, I would lose my job. It would be personally devastating. I couldn’t keep my apartment, and would find myself dependent on my parents who themselves have many health issues. The pain medication doesn’t make the pain go away… and I don’t expect it to, but it does help me do what I need to do…

    … to keep my life “together.”

    I believe what happens with addiction is that the medication makes life FALL APART.

    And that’s the crucial difference. That’s where addicts and pain patients are being lumped together when we have our own unique set of needs.

    I sincerely wish you well, and I’m so very sorry that we talk under these circumstances. What you feel is legitimate and valid, but I pray you’ll see that the “Big Picture” is very large and very complicated.

  3. Jean Price at 9:58 am

    MaryBeth…you have experienced one of the worst things a parent can go through, the loss of a child. And I’m so sorry this happened to your son. Not knowing what his pain was from, I would also think his dosage was exorbitant. However, you may not be aware that his situation is NOT the norm, since MOST PEOPLE IN PAIN ARE DENIED MEDICATION OR HAVE IT SIGNIFICANTLY REDUCED, And only about two to four percent of those who are legally prescribed pain medication ever go on to abuse their meds or fall into addiction. (You did not say if this was part of his issue or the reason for his overdose…or if it was perhaps from his level of pain or the hopelessness of living with persistent pain like many have. And yet, when we lose a child, its difficult to consider that ANY of this matters!). I also am an RN, and a person who has lived with daily pain for over twenty five years. The “pill mill” type clinics you speak of are mostly non existent now, and that is a positive step. However, the witchhunt mentality of “all opioids are bad” has spilled over to deny those who use them appropriately, legally, with careful followup…to treat their life limiting pain. And this is unconscionable, and not even medically sound! As a nurse, I am ashamed of the lack of compassionate care given to those in pain. Pain is no longer even seen as the real diagnosis…but rather an “opioid dependent disorder”! How sad and abusive this has become!! Even now affecting post surgical pain and trauma pain, plus those with end of life conditions who are in pain and being denied effective, appropriate opioid medications! I doubt you as a nurse would deny pain medication to someone in the ER with a broken hip, or someone who just had a hysterectomy…but this IS happening! As a patient, I am angry! Like many others, my daily function is now decreased FURTHER and DICTATED by the amount of medication I receive to help my pain level be less! Most of us have multiple pain issues, and are severely limited without opioid medication. Some have even committed suicide, rather than facing daily unlivable pain! Please know not all pain clinics are as you say. Family doctors have stopped treating persistent pain for their patients, so we were forced into pain clinics…not by medically sound reasoning, but rather by the absurdity of those thinking decreasing pain medication would have an effect on the HEROIN use in this country! Family doctors didn’t want their offices interrupted by the “gestapo tactics” or risk imprisonment, even though they were not inappropriate with their treatment! I was told by mine he would no longer prescribe my pain medication “because of Michael Jackson’s death, and it had nothing to do with me!” Yet, the real reason for all this discrimination against those in pain…is because some high up people in the CDC actually OWN drug rehab facilities and want to push everyone into the category of “addict”, even those who have never ever used their medication non compliantly!

    I write this to you because I wanted you to know that…your son’s prescription DID seem way too high; not all pain clinics are like you experienced; the sensationalized rhetoric and deceit of some in our agencies is keeping those with daily, persistent pain from receiving ANY opioid medication when they have tried everything else to no avail! (Most of us use multiple pain treatment modalities, yet none would be possible without opioids to lessen the pain…it’s hard to meditate or go to PT or visit the acupuncturist or get an injection of steroids when you barely can get out of bed.). We both know there are good doctors and bad doctors…and this has always been true. Yet good doctors now have their hands tied in helping their patients with pain, and bad doctors just abandoned their patients altogether! Finally, I cannot imagine how hard it is for you to have lost a son, especially as a nurse… to poor medical practice and probable overprescribing. Yet, I would ask you to consider also how hard it is to understand our situation with daily pain…without medication to ease a part of it. Neither is the right and proper course, and the CDC and DEA are only making heroin more sought after by addicts, and pain medication less available to those who can’t function without it. I pray for a better answer for all of us.

  4. Barbara Hite at 3:52 pm

    I have chronic pain, discectomy , fibromyalgia along with evil migraines since my 20’s, I’m now 51. Doctors say I’m a difficult patient, do to alot of allergies and an array of different “PROBLEMS”. I can’t find a dr to write pain meds to stop pain, beyond a 7+ on a daily basis. When they do its limited. Pharmacist give me the evil eye, my insurance dont want to cover my RX that my Dr wrote. If by some chance I can’t handle all this pain and have to go to the ER to get relief from a 10 they say I’m an ADDICT, which I’m not, because I have gone weeks without my pain meds because I can’t afford them(800.00) a month for cash price for Fentenyl patches when the insurance decided that they don’t want to pay for this month, so I have to wait 30 days then they will pay for next month’s supply. How is this legal? I get treated worst then my family dog. Now tell me that the government has their nose in my hippa form…even the next door neighbor went to jail for leaving his dog in his car with all his windows down on a 70 degree day for cruelty to animals, but I can go without my Fentenyl patches for 30 days and screaming in pain where I can’t even get out of bed because my back hurts so bad, and my head hurts that I want to blow my brains out, but ER drs. said I had been in the ER too much this year(only the 3rd time this year ) and I was there for narcotics and was acting like an addict. I was as calm as could be, polite to everyone, my BP was 156/92 pulse rate 122…..I was in pain, not their for a fix. How has America gotten this far out of control? yes, I’m a white, female, lower middle class. But treated like a Bigfoot! How Unfair! all I can do is cry. Can anyone help me?

  5. Tim Mason at 5:26 pm

    The pharmaceutical industry is largely driven by the Marketing Division. Research submits a formula and marketing weighs on what kind of revenue it could generate. Then the formula is placed at “Gate Stage” with all departments weighing in. Competitors are discussed and the race begins. First for the formulation is the “Stability testing”. Under FDA protocol if the efficacy and product characteristic are still as good after 3 months at 30 and 40 degrees at 75% relative humidity, the product can have a presumed shelf life of 1 year. Of course these same solid dosage forms have to pass “dissolution studies” (how does it dissolve in the gut and how much drug is available at that time” All this testing is costly. Some companies connected to a University, grant money may be used and even some graduated students may even do some of the work.
    After all is said and done the goal is go SELL AS MUCH AS POSSIBLE. MARKET AGRESSIVELY. Feed the doctors and staff a good lunch leave plenty of sample to hand out and well…That’s how it is done.
    Drug companies may very little on a 30mg dose of a generic opioid or 5mg dose of a anxiety medication that has been around since the 60’s. The older drugs work and work well. But this does not generate great revenue for the drug or medical device maker. These folks (driven my stockholders and marketing) want and demand a 20% growth in profit every Quarter of the physical year.

  6. Anonymous at 8:24 am

    HJ’s example illustrates an important aspect of this issue.

    We all know our own bodies. There can be many reasons extended release medication is not the best option – it definitely shouldn’t be the only one. I happen to have an adverse autoimmune-type response to them which actually causes more pain.

    It should go without saying that all patients are individuals. Forcing us into a one size fits all box is just one more example of unfair treatment.

  7. Christina at 6:52 am

    There’s drugs are being pushed by the government too of course in the wrong direction. The plastic and other crap they are putting in them will have long term effects on the body. This is why I think they should not get fast drug approvals like they do. You need to leave science to gene development and the science of preventing our bad genes from becoming active diseases we can’t shut off. Opioids are not the best thing to put in our body in the current forms there in so making them more proofed for deterrent will not end well. I tried one of those formulations and threw up thirty mins later. I will not be forced to take it and the insurance companies expecially Medicaid are pushing these meds on people.

  8. Tim Mason at 5:50 pm

    I take MSContin and the dose used to last 8 hours now it only lasts 6. I have oxycodone for breakthrough pain and I am using more of them due to the decreased efficacy.
    I have taken Roxicodone before and it works really fast but is short lived as well.
    I used to take 20mg OxyContin three times a day with oxymorphone for breakthrough pain.
    Now, I don’t seem to need as much since a total hip replacement and an ALIF 360 with instrumentation. However, the disc above the fusion became extruded bilaterally and touching both exiting L5 nerve roots. An MRI last week due to burning shins, crushing feeling on the tops of my feet along with a 10+++ pain level in the morning (area of the fusion) is killing me.
    I went to my neurologist and surgeon with the MRI and he said you have so much scar tissue that is preventing the steroid injections from working. Plus your S1 descending nerve root is encased in scar tissue. You are not a candidate for surgery and the images indicates central canal stenosis at level above fusion. He said on a scale of 1 to 10 with 10 being the worst you are a 6. You will probably be in a wheelchair within 2 years.
    PM keeps pushing several SCSs. Low frequency (old school) and high frequency (new school). Neurosurgeon said DO NOT GET ONE. You will need more images if you lose bowel or bladder control.
    I guess if the PM folks sell so many they get a free trip to Disney World.

  9. HJ at 5:35 pm

    What’s the US Pain Foundation’s interest? To see their name along side PROP is frightening.

    Are they somehow going to profit from these new brand-name copay drugs????

    Please educate me. Why did they sign off on it?

    It feels like it’s going to come down to “If you really hurt that much, then you’ll pay whatever we tell you to pay for these drugs.”

    I’m on regular tramadol and it helps me, thank goodness. It looked like my insurance was going to force me onto the extended-release formulation. I talked to my doctor and was relieved that she understood why this was alarming to me. I have MUCH more control over my pain levels when I control when I take my medications. There are days when I can skip a dose because I’m not planning to be as active or maybe there was nice weather. I wish I could say I slept well and didn’t need a dose, but that doesn’t happen anymore for me. There are plenty of reasons why flexibility is a benefit.

    Actually, here’s a reason I want to avoid the extended-release version. At night-time, I take two tramadol to help me sleep (OK by my doctor). If I had to take one dose a day, does that mean I’ll take it in the morning and not sleep well at night??? Or, am I going to take it at night and maybe struggle during the day?

    What if I have drowsiness??? I could take a medication when I know I’m not going to be behind the wheel for awhile. Ironically enough, it’s harder to plan around side effects for an extended release medication. In real life, we have variations in symptoms and side-effects that an enforced extended-release dosing would not allow us to compensate for.

    It’s easier when I can predict when side-effects may hit. For example, in the summertime, I avoid taking my tramadol before I leave for work because I’m likely to have a sweating fit and overheat on warm/humid mornings if I have tramadol in my system. Same thing in the evening — best to wait until I’m home so I don’t overheat on my way home.

    Timing of effects are important in effectively treating pain AND avoiding side-effects at times that are harmful for patients.

  10. Richard A. Lawhern, Ph.D. at 2:49 pm

    I wonder if any of the readers of this article have first-hand experience with the effectiveness of extended-release opioid formulations in both chronic pain and breakthrough pain? In the support work that I do with chronic neuralgia patients, some of those managed on opioids report that extended-release formulations are not nearly as effective in controlling disabling surges of pain as the standard varieties.

    And for MaryBeth Cichocki, I respect and acknowledge your pain in losing a son. But I must still ask that you identify a source for the 25% statistic that you quote. How was that figure arrived at? In a time when pain management practices are being driven out of business by DEA all over the US, is it possible that the “over-prescribing” practices of some of the remaining groups are a consequence of increased demand by patients who have been deserted by their long-time prescribers?

  11. MaryBeth Cichocki at 2:51 pm

    Overprescribing pill mill doctors disguised as a Pain Management Practice in Delaware are responsible for over 25% of opioids floating around my state. They accept no insurance, suggest no alternative method for pain control and accept cash or credit cards only. Being a Registered Nurse, I reported their prescribing habits after seeing my sons scripts for Percocet 30mg 129 a month!!! I was told by the Delaware Board of Medicine that they found no fault in this practice and their prescribing methods. My son is dead. Overdosed on legal prescription drugs and this practice continues to operate under the guise of caring about their patients. Physicians along with Big Pharma started this epidemic and they now have a responsibility to stop it. We must hold these overprescribing physicians responsible for the harm they do by revoking licenses and prosecuting them for loss of life.

  12. Martha S. Mayes at 2:25 pm

    I am wondering if any of you were watching the Dr. Drew Penski show last night. They featured a 14 year old girl who wants to end her life because of chronic pain, among other things. Even though the girl is only 14, several of Dr. Drew’s guest said she has the right to end her life. One reason they gave, over and over, is that she has chronic pain. Not one person said to treat the chronic pain. I guess they would rather see her dead then treated. So that maybe means that all of us chronic pain patients can have access to assisted suicide, but not to pain medication. I did not realize society had sunk this low.

  13. Cerys at 12:49 pm

    Tim is absolutely correct in raising concerns about the impact of these new formulations on GI function (which for a lot of pain patients is impaired). Not only will the formulations be difficult to break down, the composition of the excipients (non-active binders) will be proprietary and “novel”. Which means those with chemical sensitivity will be at risk. Add all this to the cost variance (it will skyrocket) and it’s easy to see why pain patients will again take the brunt of these “reforms”. However necessary these may be for addicts (testing is usually about their “preference” btw) the reality is most pain patients utilize rx meds appropriately. We continue to be lumped together with recreational abusers. This is just plain wrong. Where are the true patient advocate groups? The ones not swayed by pharma dollars? So discouraging.

  14. Nancy at 5:25 am

    Physicians for Responsible Opioid Prescribing is an organization that recommends NO opioid prescribing especially for any chronic pain diagnosis. They are not open to any other options. They are not impartial. Pain patients clearly know what works and what doesn’t and what would work if covered by insurance for alternative therapies. PROP is not going to be open to long term opioids as they are against all opioids.

  15. Tim Mason at 3:41 am

    ◾Arymo™ ER (morphine extended release, Egalet Corporation)
    The above formulation is the only one I have had time to look at.
    Other than the dissolution rate (possibly reduced) there could be a risk to those with ulcerative colitis. The thinking is that the tablet which cannot be reduced to powder with a 10 or 20 pound hammer may lodge in the colon creating an emergency situation.
    Any one suffering from colitis knows how sick one can become by eating seeds that are not chewed, i.e. sesame seeds, strawberry and tomato seeds.
    Trying to find dissolution rate data would be nearly impossible and any analytical procedure outside of the United States Pharmacopeia is considered a proprietary secret.