FDA Gives Nod to Abuse-Deterrent ER Hydrocodone

FDA Gives Nod to Abuse-Deterrent ER Hydrocodone

By Staff

The FDA has given the nod to an extended-release, abuse-deterrent opioid that’s approved for the management of severe pain for which alternative treatment options are inadequate.  Called Vantrela ER, the hydrocodone bitartrate will be made available as 15 mg, 30 mg, 45 mg, 60 mg and 90 mg strength dosages according to its manufacturer, Teva Pharmaceuticals, Inc.

Vantrela ER’s approval comes on the heels of clinical studies that evaluated the safety and efficacy of the drug, as well as its abuse potential in laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential (CAP) studies.

“Teva understands the risk of prescription drug abuse is a challenge healthcare professionals face when treating millions of Americans affected by chronic pain,” said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva in a news announcement.  “Abuse-deterrent treatments provide options for prescribers that may help deter or mitigate abuse while still preserving access to pain medications for the patients that need them most.”

The company describes the drug’s abuse-deterrent properties as being expected to reduce, but not totally prevent, oral, intranasal and intravenous abuse of the drug when the tablets are manipulated.  As an opioid, the drug carries serious risks, such that the prescribing information a Boxed Warning, which the FDA now requires for opioid analgesics.

“While no technology can completely eliminate abuse, Teva’s proprietary abuse deterrence technology is an important step forward. We are committed to furthering responsible pain management,” said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva.

According to the company, the clinical trial showed that adverse reactions occurred in ≥2% of patients in placebo-controlled trials include nausea, constipation, headache, somnolence, vomiting, dizziness, pruritus, fatigue, dry mouth, diarrhea, insomnia, and anxiety.

The full prescribing information, including the Boxed Warning and medication guide for Vantrela ER is available here.

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Authored by: Staff

There are 22 comments for this article
  1. Virginia Holmes at 4:57 am

    I have Brain Cancer and now it has spread to the skull bone, Severe Hydrocephalus pushing my brain causing the brain stem and the cerebellum (which separated from the brain) to be forced down into the opening of the base of the skull into the spinal cord. I have a metal fusion plate holding my neck together. WHICH MOVED!! I PASSED OUT TRYING TO CROSS A STREET RIGHT IN FRINT OF MY APARTMENT. ONLY ONE PERSON DRAGGED ME AND MY SERVICE DOG OUT OF THE MIDDLE OF THE ROAD. HE SAID MY HEAD BOUNCED 3 TIMES. RUSHED TO THE HOSPITAL. TO FIND OUT HOW BAD IT IS THAT I AM DYING A HORRIBLE AGONIZING DEATH. WITH A BROKEN SHOULDER AND THE BLOOD AND BONE MARROW CANCER HAS EATEN MORE THAN HALF OF MY LEFT HIP AND BONES. I have spinal stenosis, scoliosis, I have cancer that started in my blood and bone marrow. Hysterectomy, breast cancer, melanomas. I had an emergency surgery 3 days after a hernia repair and adhesions removed internally, another melanoma removed.Well 3 days after I woke up the horribble pain started and orange sized aggressive tumor on the posterior of the left leg. In one hour I was rushed into surgery, the surgeon said he was in a hurry. He took the tumor and CUT MY HAMSTRING AND TENDONS WHICH ARE NOW AT THE BACK OF MY KNEE. I CAN’T TOUCH THE BACK OF MY LEG . I WENT . SEPTIC FOR 3 MONTHS BEGGING FOR PROPER WOUND CARE. NOPE. IT ATE AN APPLE SIZED HOLE ALL THE WAY TO THE BONE AND A HEMATOMA LIKE THE SIZE OF 6″ SUB, I CAN NO LONGER TOUCH THE BACK OF MY ENTIRE LEFT LEG WITHOUT SCREAMING. BUT THESE GOVERNMENT OFFICIALS HAVE NO PRBLEMS WATCH PEOPLE DIE! I HAD A VALVE PROBLEM BEFORE THIS. I WENT TO HOSPITAL SO MANY TIMES, NOW UNABLE TO WALK SIT. 103 FEVERS. PASSING OUT. I WAS SHOVED OUT OF ST. ELIZABETHS. I DIDN’T WANT PAIN MEDS I WANTED SOMEONE TO CUT MY LEG OFF. THEY KICKED ME OUT SAYING THEY NEEDED THE BED. NO BLOOD WORK, FLUIDS, ANTIBIOTICS. NOTHING . I WAS FOUND ON MY LIVING ROOM THE NEXT DAY WITH BARELY A PULSE AND THEY COULDN’T FIND A BLOOD PRESSURE. I DIED MORE THAN 7 TIMES.I HAD SO MUCH NECROTIC TISSUE, IT WAS HORRIBLE. PUT ON THE WOUND VAC, WHICH CAUSED MORE PAIN, MORE THAN YOU CAN BELIEVE. FOR 21/2 MONTHS I WORE THAT MACHINE. THE WOUND CLOSED FROM THE OUT SIDE WHILE INSIDE I WAS SEVERELY SEPTIC AGAIN, RUSHED INTO SURGERY BY DIFFERENT SURGEONS. I HAVE A HUGE HOLE FROM ONE SIDE OF MY LEG TO THE OTHER. I CAN BARELY WALK, FUNCTION, NOTHING.THE DOCTORS TOOK ALL MY PAIN MEDS AWAY AND 2 WEEKS LATER I HAD A HEART ATTACK!!!!TO FIND OUT I NEED A BYPASS SURGERY AND THE ARTERIES NEED TO HAVE THE CALCIFICATION TAKEN OUT AND PUT STENTS IN,.ALSO THE ATRIAL SIDE IS ENLARGED DUE TO TRYING TO COMPENSATE DUE TO THE TRICUSPID VALVE IS NOT PROPERLY WORKING ANYMORE. I AM IN SO MUCH PAIN I CANNOT FUNCTION I HAVE AIDS , A WHEEL CHAIR A SERVICE DOG THAT CAN TELL WHEN MY BLOOD PRESSURE DROPS IF NOT I WILL DIE ALSO HAVING TO HAVE AIDS HERE ALL THE TIME. I CAN’T EVEN SLEEP IN MY OWN BED ANYMORE DUE TO AGAIN MY BLOOD PRESSURE DROPS WHEN I SLEEP SO IF MY SERVICE DOG CANNOT WAKE ME CONNSCIOUS THE AID HAS TO!!!!!!!!!! IN NY GORVENOR CUOMO SIGNED A BILL SAYING TO TAKE ALL, ALL PAIN MEDS AWAY. MY DOCTORS PROMISED I WOULDN’T SUFFER AS I DIE. BUT THEY LIED………………………….I AM DYING A HORIBBLE DEATH I HAVE HAD OTHER CANCER PATIENT FRIENDS HAVE HAD THEIR MEDS TAKEN AWAY AND THEY COMMITTED SUICIDE AND IT’S ONLY GETTING WORSE. THE PAIN MANAGEMENT DOCTORS HERE ARE NOW WEARING EAR BUDS. THE WON’T REMOVE THEM. THIS IS COMPLETELY ILLEGAL, IT’S LIKE HAVING A CAMERA IN THE ROOM WITH YOUR DOCTOR. LOOK IT UP PEOPLE ……..THE ONES THAT REALLY NEED THE HELP WITH PAIN MEDICATIONS ARE AND HAVE HAD THEIR MEDS TAKEN AWAY. IT’S ALL OVER THE NEWS, GORVENOR CUOMO IS GOING TO LIE THROUGH HIS TEETH THAT WE ARE ALL GETTING OUR MEDS……………..LIAR!!!!!!!!!!!!!!!!!! MY FRIENDS AND I CAN’T TAKE THE AGONIZING PAIN AND MY CANCER AND FIBROMYALGIA AND OTHER FRIENDS IN LIFE LONG PAIN ARE KILLING THEMSELVES….YOU THOUGHT THE OVERDOSING WAS BAD, SUICIDE RATES HAVE GONE VERY HIGH AND ARE STILL CLIMBING. THIS IS THE TRUTH…….

  2. R John Donahue at 9:26 pm

    Well stated, all. Esp. Sher, as far as impact per word. We need THESE voices and others I see on online forums, groups, etc., to get out there in the internet/media public consciousness. We must somehow spread these voices far/wide to counter the CDC’s statistitricks, to end the DEA’s rape of patients by which it hopes to survive though outmoded, and to expose big media’s constant passing along of these pharma-corrupted pain-patient-hating agencies’ unchallenged anti-science propaganda. How? Aye, there’s the rub. Hard to think when migrainous.

  3. Patricia at 2:33 pm

    I’m looking around seeing all what is being said the first thing is that I’m a I’m in prison in the name is Pain I’ve had 3 back surgeries a 8 hour neck surgery they took 3 of my disc out an replaced it with donors bone two fusions in my back so my back has 4 plaits two pins 4 screws 4 nuts an a pain pump in my right hip an a catheter runs from the pump to about mid up my back my neck is a cage plait pins an the other disc are collapsing and in my tummy I have a mess for a Hernia I have a petite ulcer that keeps flaring up that I can’t eat every 3 days I have to go to the hospital to get fluid both of my hands have been done twice on both hands at the same time in the last 5 years ago and 5 years before then I have P.T.S.D from what happened to me as a child I’m on depression medication anxiety mess an I way just on Percocet 10mg now I’m on Percocet and fentanyl transdermal system 25 mcg/ hr because of my hips and legs and back is gotten bad I had a M.R.A it’s how they can check the blood flow from the hip to the legs an my right is real bad bearly getting blood flow the left isn’t for behind an I will be in a wheelchair and then another surgery I’ve lost count an as for the drug test I don’t mind but every 24 days come on don’t need it that often an I agree about the doctors treament of me as a person as equal as her no she looks at me as I’m a nobody I’m a mother of 3 a grandmother I’m a wife I’m the lady next to you I treat every person equal why can’t I be treated as a person one of Gods children I can’t control what is happening to my back I didn’t ask to slip on that peace of black ice I was just going to work just like anyone else An the other day I was on a page on Facebook an so many innocent people talking about what would happen if they took their life line and yes it’s medicine want they just legalize medical marijuana you don’t have to smoke it it’s good in a brownie an you can’t even have it because it’s legal in Louisiana medical marijuana is but you can get it right now they don’t know how they are going to do it how to dispens it they can do it like I have to carry a card so I can go through the thing at the airport an in the courthouse because of my pump and all the pins an plaits in me but hell its legal I always knew Louisiana didn’t have very smart people in our government I mean how many people in the Louisiana government to screw in a lightbulb I hope each an everyone of you be blessed with some pain relief God bless everyone

  4. bert espinoza at 9:46 am

    After reading, Jean price, comments, I will have to agree, about 99% ,of what was said..the big problem,is all these comments,in one form or another,must be put into reality,or motion..

  5. Jean Price at 11:00 pm

    I don’t think the extended release medications have improved my life. Or my pain level! Most people I know with chronic pain have a level they expec and have learned to live around….yet they need medication for the acute flares that activity can bring, or the days that pain just increases without a discernible trigger. I did better when I could regulate the amount I had in my system…and I could be more likely to drive for an brief errand. Not now, though…the consequences are more than I’m willing to risk, even though I feel as capable as I was driving in some pain, unmediated!

    That being said, I am all for abuse deterrent meds…IF
    *they work as well or better.
    *they aren’t way more expensive.
    *allow doctors to start prescribing opioids as needed again.
    *will actually dissolve in the system, confirmed by bioavailability testing.
    *will not cause side effects due to the deterrent agent
    *do not have another medication combined, like Narcan!
    However, in my experience, the medication (not the one in the article) didn’t get into my system effectively. A larger dose was needed for some reason to produce even a similar effect. They were very expensive. And I’ve yet to see any Doctors starting to use these abuse deterrent medications as needed for those in pain.

    I wonder if this was a randomized double blind, placebo controlled study comparing the new drug to the KNOWN medication (without the deterrent part), how many patients were involved, and what type of pain they had to qualify. If this was not a comparison study…then the results mean nothing in my book! (I’m not sure how it could be done like that either, since the dosing would have to be different and that would automatically make it not a blinded study!). So I’d have to know these things before I could say… oh great…or yah right, nothing good here!

    This seems like a lot of effort…when those who take pain medication aren’t the problem here! And will it really help anyone who wants to abuse these meds…people can get very creative when addiction is the motivator!! The only ones likely to gain from all of this is the pharmaceutical company…and their bottom line profits shouldn’t be our problem! We have enough issues already, with pain! We don’t need to support them by paying for expensive drugs! Especially when there are much less expensive ones and much more effective ones already!

  6. Anonymous at 11:25 am

    Michele, unfortunately I cannot shed any light on it, but experience the same problem with any of these formulations.

  7. Michele at 2:58 pm

    hi all, my comment is specific to the ‘abuse-deterrent’ formulations of any/all opioids…while i do agree with you all about letting the physicians take care of the patients, get BigPharma in control or cage it rather than doing so to legitimate patients, and the insurance aspect of all this, getting the government on the right track – which is their ‘war on drugs’ campaign just keep that ‘war’ on the people in it, not the by-standers….ok, so my point is has anyone had problems with taking the abuse deterrent formulations? severe side effects? i realize many say they are much shorter acting than the extended version says its good for and that most say they’ve experienced withdrawal effects/not equal to the dose of IR dosages of same drug….i have tried nearly and quite possibly every long-acting and abuse-deterrent opioids out there and every single time i experience SE mostly mood/emotional/mental status changes. i have been tested for metabolic rate of absorption/excretion as well as an array regarding which medications are the best for me / my body / my diagnoses in development of a treatment /medication plan. i’ve made many attempts researching this dilemma and to query with the drug manufacturers as well as the investigations my doctors have done…no one can explain what chemical(s) or changes on molecular level that cause me/my body to basically reject these drugs, and this goes for ANY long-acting/extended release formulation of other drugs as well….just wondering if anyone has experienced this or whomever might be able to shed light on this problem…much thx

  8. bert espinoza at 2:27 pm

    Again,let’s talk about the opioid crisis. Wake up,doctors,pharmacists,politicians, f.d.a.,d.e.a.,c.d.c.,senators,congress,Whitehouse etc.etc.
    Regardless,of what is happening, their will be even much,much bigger,crisis,comming.we now have a 25%reduction for opioid in 2017. Add many doctors,are scared to prescribe, pain meds, due to losing their license.or being intimidated. So the way it’s seems to be going is, that millions of good American folk,will suffer,greatly, by,withdrawal,not being productive, quality of live will be bad, can,work,or function. Depression,will hit a very high period.shall we go on and on?????. And we worry about the folks, who overdose, do wrong. Unlawfully deal,mix with other stuff.and unfortunately die…let’s look at the bigger,bigger picture please..

  9. Mathew at 10:57 am

    I am currently watching C-SPAN’s coverage of the Senate confirmation hearings for Dr. Price, now 3 1/2 hours of water boarding the Rep. of Georgia. I was a bit concerned when he agreed with the blanket statement that we have an opioid epidemic without clarification between CPP’s and street addiction. I hope the Honorable Congressman is not going to change his stripes.

    Yes, everyone is different where opioid pain medication is concerned. Size, weight, absorption rate, which is why the guidelines are absolute ridiculousness.
    Here is a great article detailing this – http://paindr.com/one-size-opioid-dose-does-not-fit-all/

    ACA = stupid is as stupid does.

    Oh and as for the euphoria I experience from taking my pain medication, well yes I guess I do. Having my pain level reduced from 9 out of 10 to 6 out of 10 is my idea of euphoria.

  10. Sher at 7:29 pm

    I agree, we need to communicate to Pres. Trump what is happening. CDC & DEA are bloated with power hungry, misinformed people who scream of opioid epidemic instead of heroin epidemic. They are losing the illegal drug war, but want the govt. $ so they go after the most vulnerable of society. Now is the time, please! Everyone write letters, make calls, we need to raise hell !!!!

  11. Loura Shares A Story at 6:27 pm

    These medications actually make addiction MORE likely. Getting the body used to constant doses of medicine means weaning off and withdrawal symptoms are much, much harder to cope with, and tolerance build up happens more quickly.

  12. Melody Templin at 4:41 pm

    I believe that this was because Big Pharma benefits from that decision. With the low cost generic painkillers made inaccessible, big Pharma is rolling out all the new pharmaceuticals. These have much higher profit margin.

  13. Michael G Langley, MD at 4:21 pm

    I might try to get a job! I could function with my spinal disability! Having a graduate school education, being board certified in general surgery, having a Certificate in Pain Studies for the University of the Pacific at Stockton, and also certified by the American Academy of Pain Management from Nevada, I would be very well educated about how to help chronic pain patients. Having become one of its victims six years ago, after breaking my back and damaging my cauda equina, I have even more ways to identify with chronic pain patients. Having been on both sides of the equation, I am very well informed! Thing is, I was never good politician. Most the doctors I was around were angry with me for invading their turf! They even dropped to the level of accusing me of acting like I was smarter than them!? Alas, politics, or a political job, is probably not for me

  14. Mathew at 2:12 pm

    Absolutely Mr. Dorn !!!
    Now that Thomas Frieden is gone, I expect President Trump to walk the talk.
    With his nominee, Dr. Price as HHS Secretary hopefully confirmed, we should expect a 180 degree turnaround.
    We should all follow your advice and remind our new President of his 100 million constituents our urgent need for his pen to sign an executive order tossing the CDC guidelines out the window; baby, bath water and all.

  15. Maureen at 1:48 pm

    Two years ago, when I moved to Fla., I was abruptly taken off of my long time meds that worked just fine for me and put on Zohydro ER when it was barely on the market (the new drug of the month!). It did not work for me, the dosing was too low and also my body processed it way too fast and therefore I was put to bed in horrific pain come 2pm every day, until I got to see my pain doc again the next month. It was awful. I also went into a degree of withdrawal and had side effects from the med. I called the company who made it and was told that for my type of pain, this was NOT the med to be on. The doc would not listen to me when I told him that.
    That new doc of mine explained nothing to me. He kept me on it for 3mths at which point I felt like a hurt and caged animal and so I took myself off and he then discharged me.
    Fast forward, next doc put me on Hysingla 24hr ER with just one breakthrough Hydro per day, also barely on the market then. I could’ve screamed and I cried all the way home that day.
    Again, I metabolized it too fast and it was not enough pain management,was put back to bed and I suffered greatly.
    He too would not listen to me and therefore I found myself yet another doc who heard me loud and clear and brought me back to my original short acting meds. I could’ve kissed her! I was so happy. But, she eventually left the group and her colleague has kept me with those meds… Now he just left the group and next month I will see a new colleague there. Oy vey!!!! it’s a rotating door there!
    Now I fear that I may be put on this one. Ugh! Pain management used to be well individualized not generalized and the governement needs to stay out of our treatment! We are being harmed, not helped.

  16. Sandy M. at 12:26 pm

    I agree, we were dropped from my husband’s insurance after he was a firefighter in our city for over 22 years. We can’t pay over $1800 a month for insurance in which we still paid over $200 each month for medications, actually more. Anyway, we feel blessed to have had the help with our insurance thru his job for those years. I had a hemorrhagic stroke in the thalamus part of the brain. This was in 2001 when I was 53 years old after more than 30 years as a legal secretary. It left me with a chronic pain condition mainly from the left side of my face to my feet. However, my husband has to help me because I am unable to do much.I has Scoliosis so bad after years of pain management clinics where I was given every injection and tests you probably have been thru also. I also had a 90% blockage in a coronary artery and had a Stent inserted. I won’t go into everything because I know most of you have been thru the same experiences. My point is it took me years and truckloads of trial and error to find medications and years of saying “NO” to an opioid. After being in such pain. I was bedridden with PAIN. It doesn’t keep me completely painless by any means, however, it does give me time to have my grandchildren visit. There are no more Thanksgiving and Christmas Eve’s dinners at grandma’s house. I have 2 wonderful daughters and families who have taken that over, and I’m not out of the house much at all. The cold and hot weather bothers my body as do clothes touching my skin. Now Medicare is refusing 3 of my medications, of course you know one of those. I’m 69 years old, I have always taken my medicine, even going over the 30 day amounts. My doctors and even our pharmacist know me, and now we have government officials telling them what to do. As has been said here, this will not stop junkies from getting HIGH, so while we are being punished from a little relief so we may maintain some type of life, the drugs will continue to be misused. We are not Addicts, we don’t take these meds to get HIGH, my gosh, I dont understand why at 69 years old, I might turn into an ADDICT, This pain along with fighting iinsurance companies to fill our doctor’s prescriptions is unbelievable and doesn’t even seem like the America I grew up with. It isn’t, I know. I don’t know what President Trump’s plans are, but it’s time to do something while we try living on budgets to even pay for the meds we need, and all the other cr*p involved while growing older, just does not seem fair.

  17. bert espinoza at 11:48 am

    Amen to that. William dorn. Needs to be done..

  18. William Dorn at 10:57 am

    Flood the White House with letters telling them to leave our medicines and doctors alone.If all 100 million people in chronic pain would do this they would listen.

  19. bert espinoza at 10:27 am

    Well as for time-release hydrocodone, fine. But is it going to cost?. Will ins. Co. Pay?. Great get the Tylenol out. Again, why do good Americans with true pain, trying to to have a better quality of life, working raising their family’s,have to suffer,and be blame, with the bad apples,who mix,sell with illegal drugs. They there for are overdosing. Etc. I have tests every year,done for my kidneys,liver etc. Just trying to be careful. Please , let’s quit punishing,the millions ,who take pain meds,to the few thousand, excluding,those who overdose, because of lack of education.with many who sell, mix etc. Then cause cause a opioid crisis.wake up America. Mr. President trump,please, consider,consider,and consider.

  20. Ben Hurtin Longfellow at 8:55 am

    Abuse deterent technology will not make governing authorities view chronic pain patients any more kindly. The road of the chronic pain patient will not widen because of deterent improvements for pain meds. Don’t understand why pharma even produces medication in different dosages. Physicians don’t have the authority to prescibe but for a set amount of dosage anyway. Hate to be negative. Chronic pain mentality kickin in for a little while.

  21. Joan Hamm at 8:41 am

    Each body is different on how Medicines affect them. What works for one may Not work for another. That is why testing is done to determine what works for relief of severe pain. No human life in our America should be refused medicines until a proper one has been tested and replaced. Go after the Drug Dealers. You know who they are and not against a sick American!! Our Constitutional rights!!! And medical care. You will become murderers of the innocent. History will prove this. This is the beginning of the end as America.. Land of the free!! Send back illegal immigrants who are not qualified to stay here without being racist. But by our rules as other Countries are starting to do. From what I have read and told.

  22. Charles at 7:25 am

    So you would have to go to the ER to get it? What’s the price? A plain old Generic opioid costs $0.01 to produce. How much do we have to pay for people who have a problem with choice making? Are you talking about the disease model from 100 years ago? If you stuck to the 1906 Pure Food and Drugs Act. Maybe we wouldn’t be in this mess! “PURE”! Not this pharma money making crap of nanny state medicine that is enslaving and making people dependent on you and not themselves is making the problem worse! Time for all these agencies to get out of the social engineering business and just make sure the medications and food don’t have chemicals not necessary or toxic in them and let people deal with their own problems with their doctor and get your butts out of our doctors offices! Freedom not dictatorial powers of governmental agencies! Your not standing behind a curtain anymore and your logic is more akin to communism than freedom!