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FDA Approves First Implant Treatment For Opioid Addiction (bloomberg.com)

An anonymous reader writes from a report via Bloomberg: The Food and Drug Administration cleared the first implant in the U.S. to treat heroin and opioid painkiller addictions. The product, Probuphine, may be used to treat addicts continuously for six months with the drug buprenorphine, according to a statement from the agency on Thursday. Titan Pharmaceuticals Inc. and partner Braeburn Pharmaceuticals are the two companies behind the implant and plan to bring it to the market just as Congress passed a bill aimed at addressing the opioid crisis. Buprenorphine differs from methadone in that it doesn't require a treatment program. Doctors can prescribe the implant to patients after they take a four-hour training program. The FDA rejected the implant in 2013 because the original dose that the companies proposed was too low to provide effective treatment. The companies decided to maintain the lower dose and attempt to gain approval by restricting use to patients who already were stable on such amounts. Meanwhile, employers are struggling to find workers who can pass a pre-employment drug test.

27 of 49 comments (clear)

  1. "Buprenorphine differs from methadone in that it.. by fred911 · · Score: 1

    .. doesn't require a treatment program"

    Nope, just an "oil-change" every six months. Sounds like a great revenue generator for the manufacture.

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  2. Re:OK by Anonymous Coward · · Score: 2, Insightful

    This is completely different.

    In that case the pharmaceutical industry is profiting by providing a "solution" to problems caused by the tobacco industry. In this case the pharmaceutical industry is profiting by providing a "solution" to addiction problems caused by the pharmaceutical industry.

    If the "solution" isn't very effective and provides on-going sales - well, that's just a lucky side-effect.

  3. Buprenorphine is a partial opioid receptor agonist by Anonymous Coward · · Score: 3, Interesting

    It's a maintenance program that's a little less vulnerable to diversion. This exists for naltrexone already (an antagonist).

    Implanting opioids inside of people probably isn't the solution to the "opioid crisis" that you're looking for. In other news, opioid overdose deaths have fallen dramatically here since a medical marijuana program was established; might consider looking in to that, guys. You know, the drug that doesn't cause respiratory depression and can't be injected.

  4. Re:OK by Razed+By+TV · · Score: 3, Informative

    The idea is to replace the drug of choice with a drug that will 1) not provide a high, and 2) reduce withdrawal symptoms.

    Treating nicotine addiction is a little different in that it usually means moving away from cigarettes (which contain addictive compounds other than nicotine). Gum and patches do not provide the other compounds. Gum/patches also don't inhibit getting pleasure from nicotine, so it is inferior to using a drug to reduce highs and withdrawals.

  5. Did anyone read/see A Clockwork Orange? by axewolf · · Score: 1, Insightful

    Well did you?

  6. Re:The struggle for workers by ruir · · Score: 1

    Or if instead of offering peanuts that only bring deadbeat people, they pay real salaries.

  7. Re:OK by ArmoredDragon · · Score: 5, Informative

    So really, this is no different than treating nicotine addiction with more nicotine (ie. gums and patches, etc).

    There's a reason we don't treat alcoholics with whiskey.

    Actually in some very rare cases you might do exactly that. Sudden alcohol cessation can have fatal consequences, even more dangerous than quitting opiates cold turkey.

  8. Methadone is all the addiction, none of the thrill by teslabox · · Score: 5, Informative

    The idea is to replace the drug of choice with a drug that will 1) not provide a high, and 2) reduce withdrawal symptoms.

    Opiate addicts are a little more functional on replacements than on heroin, but this is only because they don't have to worry about how they're going to "stay well". People can be functional heroin addicts if they don't have to worry about sourcing their next dose. In Chasing the Scream, Johann Hari says that some countries give the give their opiate addicts all the heroin they need, and provide a safe, supervised environment for use. Most addicts eventually age out of their addiction.

    I met a real drug addict about a year ago, but I didn't realize it at the time. She fluttered from topic to topic like a butterfly, and I said, to myself, "this woman is high as a kite..." She told me about going to the Methadone clinic every day. She gradually invited me into her world, and I learned that the methadone wasn't enough to fill the "holes in her soul". She supplemented her opiates with the street pharmacy's medicines.

    With my influence, by about six months she was doing much better. She quit methadone and alcohol cold-turkey. Then the mental health system got a hold of her, and it's been a real struggle ever since.

    Calling the mental health system "Psychiatric torture" is not fair to the suffering endured by people who've actually been tortured, but it precisely describes the hopelessness and futility endured by people who are "treated" with drugs that do not address any of the causes of their condition. "Psychiatric Abuse" will have to suffice.

    She got addicted to anxiety medications during her fifth mental hospital stay. She'd only wanted them as-needed, but they forced her to take that pill every day. Two weeks after she was released, she hatched a stupid plan to get through the benzodiazepine withdrawal. We got together the second night of her stupid plan, and had a little fight. She said that I didn't understand that she wasn't going to get addicted again, she just needed it so she could sleep. She said it was barely any heroin at all, and just to spite me, she prepared a second shot and did that too.

    When she revived, she was immediately terrified by the sudden presence of people in uniform. The firefighters should've followed protocol and taken her to the hospital, but I'd told them that she was already on court-ordered treatment, so they decided to just disappear into the night. After a few more minutes, the police decided they could leave too. The only evidence I have that anyone was there is the nebulizer used to squirt the anti-opiate drug into her nose.

    She did very well for the next two weeks. But I was 2 hours away, and she was left to take care of herself, with the added burden of having to take court-ordered anti-psychotic sedatives. She was back in the mental hospital about 5 weeks after her release from the fifth mental hospital stay.

    Psychiatrists must be trained to not care why their patients are in their care. They gave her a new anti-psychotic, but she was still quite delusional when she was released from her sixth mental hospitalization.

    By this point I'd obtained the drug that she actually needed. It worked exactly as I thought it would, I brought her to live closer to me, and she started to recover from her anti-psychotic-induced brain trauma. Her new psychiatric nurse initially wanted her to stay on the anti-psychotic sedative, but eventually realized the patient doesn't actually need to be permanently sedated.

    But she ran out of anxiety medication recently... Her new court-ordered-treatment provider said they didn't provide those drugs, so my friend went to source them from her old "friends". Street drugs are much easier to source than specific second-hand prescription medications.

    Street drugs caused her to become psychotic again. She would have come out o

  9. Re:OK by Anonymous Coward · · Score: 3, Informative

    Buperinophine doesn't prevent you from getting high, and you can ask the users of Suboxone about that. It is still possible to get high and feel good from buperinorphine which means even if you have this implant you can still get high and abuse it by taking additional buperinorphine. In terms of stopping withdrawal symptoms,bupe does it the same way heroin does it: By activating the mu-opioid receptor. That means when it comes time to remove the implant or when the dose starts to go down, the user WILL experience opioid withdrawal symptoms. The only thing bupe and methadone do is put off the withdrawal symptoms for a later time, but you still have to go through them.

    So in however many weeks or months when the implant starts to lose its effectiveness cravings will come back and the user will either need to get a new implant or deal with the cravings and withdrawal. There is absolutely no way around this (I can tell you this as someone who just finished opioid replacement therapy with methadone and then subutex and I'm going through withdrawal RIGHT NOW). Tapering is the only effective treatment in terms of alleviating withdrawal symptoms (beside from ibogaine).

    No matter what, the golden rule is this: If you take an opioid to stop opioid withdrawal, you WILL eventually have to go through withdrawal. You are just putting it off for now. Buprinorphine IS AN OPIOID. The comparison between nicotine replacement therapy and opioid replacement therapy is apt. Its not getting you off the addictive substance, its getting you off the harmful method of consumption (inhalation of smoke for tobacco and injection/use of impure heroin with opioids). You still have to do the hard work of getting clean and replacing the habits you had before with new ones that aren't related to drugs.

    To say that this is a treatment for addiction is absolute bullshit. This is just a maintenance drug, nothing more. It goes in the same category as Methadone and Suboxone: A drug to keep you addicted. That may sound tin-foil-hat but when you know there are more effective drugs that actually DO treat the addiction (like Ibogaine and its much safer analog, 18-methoxycoronaridine) you start to see the greed at work. Pharmaceutical companies can either make a product that cost them next to nothing, is already in use in the medical community, and provides a GUARANTEE that the patient WILL have to come back for more, its a home run. Its a license to print money. You have a drug that is highly addictive, and you are selling it to people as a way to get off some other highly addictive drug. Now lets look at 18-MC. It will cost those drug companies a good amount of money to bring it to market and they wont have a repeat customer. 18-MC, and ibogaine, have shown incredible efficacy in actually STOPPING addiction. Not calming it down, or pushing the withdrawal symptoms back, or maintaining. Ibogaine and 18-MC can full-on stop addiction right in its tracks. You stop craving, you don't have withdrawal symptoms, you are FREE of the drug. And its a single dose.


    I'm rambling now so I'll just summarize by saying this. This is not an anti-addiction treatment. Its a maintenance treatment, nothing more. Its a way for pharmaceutical companies to make money while saying they are doing something about the addictive drugs they make. There exists a drug that can actually, for realsies, "cure" addiction but since it won't make as much money they won't even consider it. The only way 18-MC even got a clinical trial was because it was also an effective treatment for leishmaniasis. If it wasn't for that, it would have NEVER been given a clinical trial.

  10. Re:OK by Anonymous Coward · · Score: 1
  11. Re:Methadone is all the addiction, none of the thr by Nehmo · · Score: 2

    I met a real drug addict about a year ago,

    I did heroin for many years. I was on methadone for years too. And now, for about 5 years, have been taking buprenorphine. There is so much written on the subject http://www.bluelight.org/vb/th..., I hesitate to add, particularly since I criticize people for tending to be long-winded on it. I currently have both Suboxone strips, for which placing under the tongue is the route of administration and Zubsolv, another formulation. I, personally, wouldn't like an implant, because you can't adjust your dose to suit the circumstances. I guess the advantage is convenience.

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    (||) Nehmo (||)
  12. Re:Buprenorphine is a partial opioid receptor agon by rtb61 · · Score: 2

    Just out of curiosity driven by this story and apart from getting to this very very suspicious site http://www.naabt.org/buprenorp... compared to this more realistic site http://www.streetinsider.com/C..., it seems like the drug and treatment might not be all it is cracked up to be. I'll bet before to long we will see lobbyists demanding it be compulsory for all opioid drug offenders, profit, profit, profit, you can really see it coming.

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    Chaos - everything, everywhere, everywhen
  13. Re:OK by swb · · Score: 3, Insightful

    There's a reason we don't treat alcoholics with whiskey.

    I suspect it's not a very good reason or a reason whose motivation is derived from Calvinistic moral calculus.

    My friend's step mother is an alcoholic and has been through a half-dozen treatment programs, most of them in-patient programs and still hasn't stopped drinking.

    What if we just acknowledged that alcoholics drink, and instead of trying to foist abstinence we instead eliminated the shame associated with "failing" to become a teetotaler and instead put some effort into just getting their drinking down to less-destructive levels?

    There were at least two NYTimes articles about this kind of thing in the past year, including a Dutch program that gave chronic alcoholics jobs *and* beer, providing them with structure that got them into a productive life cycle but acknowledged that they could drink, too? From the looks of it, it appeared to be fairly successful. The key things seem to be getting into life patterns that provide meaning and teaching them to drink at levels that are much less destructive. Eliminating the shame associated with drinking seems to be important to this.

    From everything I've read, psychiatrists consider buprenorphine an extremely good treatment for opioid addiction. If getting opioid addicts on a stable maintenance dose and back into constructive life habits works for them, why couldn't something similar work for alcoholics?

    The relentless focus on total abstinence seems bizarre in comparison to, say, people with depression whom we *encourage* to take maintenance doses of anti-depressants without relentless shaming of those who can't "just get better" and stop taking them.

    It would not surprise me at all if we ever found out that some people are biologically susceptible to alcoholism or opioid addiction due to brain chemistry imbalances, just as some people are prone to depression for the same reasons.

  14. Will we ever just invent smart recreational drugs? by swb · · Score: 2

    As much as society struggles with drug addiction, I'm surprised we haven't figured out that maybe the better solution is invent better recreational drugs. Drugs purposefully engineered to provide euphoria similar to street drugs, but engineered to limit the risks of overdose and abuse.

    Could they engineer a drug that provided a high with the first dose but for which subsequent doses had an exponentially decreasing marginal utility or which couldn't be taken again for any increase or new high until some hours had passed? Some of this may just be a question of formulation, with a dose of a time-release longer-life agonist that both eventually reduced the high and blocked any new high from happening.

    You can come up with a bunch of engineering goals that would allow for a person to take such drug and make abuse very difficult due to limited repeat use, lack of overdose potential, etc.

    The biggest part problem we seem to have with drugs is the relentless notion that taking any substance to enjoy a euphoria is wrong, leading us to just hang onto a whole panoply of drugs that have nasty side effects or risks. What if instead of continuing to fail to eliminate them, we simply out-competed the old drugs in the market by replacing them with better, cheaper safer drugs?

    I think legalizing marijuana is part of this, because it actually has a lot of the qualities of a better drug -- once you're stoned, it's less useful to smoke more pot while you're stoned and at a certain point more pot doesn't really make you more high. It has an extremely low overdose potential, is non-addictive and doesn't produce much in the way of chronic health problems (smoking aside).

  15. Get politicians out of health care by dcollins117 · · Score: 1

    It really concerns me that Congress thinks it knows better than doctors do and now want to "train" doctors how to prescribe opiod pain medications. In my state there's talk about restricting the amount a doctor can prescribe to three days worth.

    This issue hits particularly close to home, as I recently broke my foot and started taking opiod pain meds. If my doctor was prohibited from prescribing an adequate course of medication my pain would be undertreated. That's not OK with me.

  16. Re:OK by Ol+Olsoc · · Score: 1

    There's a reason we don't treat alcoholics with whiskey.

    I suspect it's not a very good reason or a reason whose motivation is derived from Calvinistic moral calculus.

    This is interesting. I don't drink very much, so can't comment on that addiction, but I can attest to the puritanical attitudes that believe that feeling good is a sin. After some sports injuries and on opiates for a short time, I do recall the burst of euphoria involved. So I understand that some could become addicted. I didn't become addicted, as so many others didn't, so it is more an issue of personality/physical makeup?

    But our war on drugs has ruined more lives than the drugs themselves. What is worse, it creates a vehicle for people to make incredible sums of money and commit impressive amounts of violence. And doesn't do a damn thing about stopping access to the drugs.

    So while an alcoholic might function quite well on controlled amounts of ethanol - and they do, I know I've worked with some very capable and professional alcoholics who were better employees than most - and there is nothing that small doses of opiates do that will incapacitate you, the concept of controlled access makes for people who are more likely to be productive citizens, and less likely to become a ward of the state.

    What if we just acknowledged that alcoholics drink, and instead of trying to foist abstinence we instead eliminated the shame associated with "failing" to become a teetotaler and instead put some effort into just getting their drinking down to less-destructive levels?

    would be a very interesting experiment. Expect a huge pushback from the Women's Christian Temperance Union H^H^H^H^H^H^H^H^H Mothers against Drunk Driving, who have exposed their inner core beliefs since largely achieving their initial goal.

    There were at least two NYTimes articles about this kind of thing in the past year, including a Dutch program that gave chronic alcoholics jobs *and* beer, providing them with structure that got them into a productive life cycle but acknowledged that they could drink, too? From the looks of it, it appeared to be fairly successful.

    There are some people who are going to be a problem, and will be on a self destructive course, perhaps not much at all can be done to treat them. But those might be outliers? Who knows - certainly worth a try.

    As well, one of the things I just recalled. My family was more European than American in my upbringing, and I had my tastes of beer and wine (usually watered down) as a child. So when I was in high school, and my friends were pretending to be adults, using the forbidden drink they could now sneak, I was largely meh, and thought them pretty ridiculous watching them stumble around and puke. It just wasn't something glamorous. But it worked.

    Today, Child protective services would have put me in foster care. All the while making more alcoholics.

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    The shepherds did so well protecting the flock that the sheep no longer believed that wolves existed.
  17. Re:OK by swb · · Score: 3, Insightful

    There are some people who are going to be a problem, and will be on a self destructive course, perhaps not much at all can be done to treat them. But those might be outliers? Who knows - certainly worth a try.

    There's a whole combination of magical thinking clustered around the idea that only total sobriety is acceptable and that alternative solutions (like maintenance dosing or harm reduction) are judged by their failures instead of their successes.

    Total sobriety has a terrible track record of success, yet it is judged by its successes and viewed as a solution because of its adherence to the ideology of total sobriety. Maintenance dosing or harm reduction is at least as successful, but is judged for its failures and condemned for its acceptance of non-sobriety.

  18. Re:OK by HornWumpus · · Score: 1

    The treatment for drinking methanol (wood alcohol) is keep the patient drunk on ethanol until the methanol has been excreted by the kidneys, about 5 days.

    Which is how serious crazy sterno drinking drunks stay alive. They never ever sober up.

    --
    John McAfee 'It was like that time I hired that Bangkok prostitute; to do my taxes, while I fucked my accountant'
  19. Re:Buprenorphine is a partial opioid receptor agon by HornWumpus · · Score: 1

    Been working on heated big bore needles for my plan to go IV on bacon grease and alfredo sauce, should work with hash oil.

    --
    John McAfee 'It was like that time I hired that Bangkok prostitute; to do my taxes, while I fucked my accountant'
  20. Re:OK by joeboomer628 · · Score: 1

    Addicts in recovery know that the only way to recover a useful life is to stop using drugs. This is best achieved by sitting down with other recovering addicts and discussing the methods they have found successful in reclaiming their lives and changing the behaviors that lead to self-destruction. The only one that can change addictive behavior is the addict him/herself. It is not easy and takes a long time. Medical and mental health professionals are useful in helping addicts with physical and mental issues associated with addiction, but they have no addiction cure yet. The good news is that this approach is widely available without charge. The only requirement is a desire to stop using.

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    JoeR
  21. Yes, drug addicts can be stable Re:Stable? by davidwr · · Score: 1

    Is there really such a thing as a stable drug addict?

    Yes, especially if "stability" means either "stable in recovery, very unlikely to relapse" (which may be "for life" for some addicts) or "recovered completely" (which is a realistic objective for some but not all addicts).

    I'm probably not the only /. poster who is "stable and recovered" from caffeine addiction: There was a time when my use was quite literally out of control. I really was an addict. I went through a period of not using it at all. Now I can - and do - drink caffeine-containing beverages responsibly and in moderation, but mainly because there is no decaffeinated version of my preferred beverage available. If I were always given the choice between that beverage and a decaf version of the same, I would almost always go with the decaf. Every now and then, I deliberately use caffeine to let me stay awake. However, if I know ahead of time that I need to be wide awake at my normal bedtime, I prefer to adjust my sleep schedule rather than relying on caffeine to keep me awake.

    Regarding being stable-and-recovered from narcotic addiction:

    A few decades ago, someone I knew was in a car wreck. He was in the hospital for many weeks. During that time, he developed a physical dependence on a particular narcotic painkiller. I don't think he became psychologically addicted though. In any case, he had to detox and from what his spouse said, he went through physical withdrawal. If my decades-old memory is correct, the detox and withdrawal were all done while he was in the hospital.

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    Knowledge is how to play a game, intelligence is how to win, wisdom is knowing what game to play.
  22. I'm afrait to see it Re: ... A Clockwork Orange? by davidwr · · Score: 1

    I'm afraid that I may become addicted to books/movies of that genre.

    Note - this may sound like a joke, but I know myself too well, I've become morbidly fascinated with unhealthy ideas from the written word before. For me at least, watching this film or reading the book is very likely unwise - I'm likely to enjoy it for all the wrong reasons. I've read synopses and reviews and that's enough to get the important social message, I don't need to read the book or see the film in all of its gory detail.

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    Knowledge is how to play a game, intelligence is how to win, wisdom is knowing what game to play.
  23. Mod parent up by davidwr · · Score: 1

    I've already posted in this thread or I would do it myself.

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    Knowledge is how to play a game, intelligence is how to win, wisdom is knowing what game to play.
  24. I call BS Re:There is no such thing as 'addiction' by davidwr · · Score: 1

    Okay, I haven't read the books, but the only way you can say "there is no such thing as addiction" is to give some other name to

    "engaging in a behavior in a compulsive way, for reasons that cannot be explained otherwise (such as because the individual has OCD, or the individual has been taught/conditioned to engage in the behavior, or some other reason)"

    In some cases, addicts take a drug only because of a physical dependence and the desire to avoid withdrawal symptoms.

    In other cases, they may take them under doctor's orders and they may not realize they are addicts until the doctor tells them to stop.

    However, In most cases where physical dependency or medical advice isn't the reason to take the drug, addicts take drugs to feel better or to "escape" from dealing with the "bad things" of life. I assume this is what you meant when you said "People take drugs because their EMOTIONS make them feel bad, period." The same goes for most gambling addicts, sex addicts, and the like. This compulsion, driven by emotions, is a definition (but not the only definition) of a behavior addiction. So, unless we are going to come up with a new term for this, we have to admit that addictions - in the sense I just described - do exist.

    You can change the name if you want to, but it won't change the fact that there are people out there who compulsively engage in some behavior - be it gambling, drug use, or what not - because their emotions make them feel bad and the behavior makes them feel less bad and/or the behavior itself makes them feel good.

    With respect to opiate addicts who are also psychologically addicted to the drug, maintenance drugs like the one described here "buy time" for the addict to develop coping mechanisms and alternative ways to deal with the unpleasant aspects of life, so that when he finally does wean himself off of the maintenance drugs and go through withdrawal, he will be much less likely to relapse during withdrawal or later, after his detox is complete.

    --
    Knowledge is how to play a game, intelligence is how to win, wisdom is knowing what game to play.
  25. Depends :) Re:its not hard to quit cold turkey. by davidwr · · Score: 1

    I quit cold turkey every year: In late November, I have cold turkey for several days in a row, but the Thanksgiving leftovers eventually run out so I quit. Yes, there are cravings, but they usually disappear after a day or two.

    --
    Knowledge is how to play a game, intelligence is how to win, wisdom is knowing what game to play.
  26. what about psychological addiction? by CoderFool · · Score: 1

    This may treat the physical addiction, but what about the psychological one? If someone turns to these drugs for relief from stress, boredom, or loneliness, then this habit will remain even though the physical 'need ' isn't there. you got a substitute for that? how about a 'soul' patch?

  27. Re:Make all opioids OTC - no script needed by Some_Llama · · Score: 1

    but then there's all that lost income to the DEA/local police/jails/politicians who are "tough on crime"/big pharma pumping out "solutions" like these.